Gilead Sciences Hammer Flush On Price Target Hike

Gilead Sciences stock has formed a bullish hammer flush on October 27, 2017 after JP Morgan Chase raised the price target to $85 (6.12% upside from the current price). JP Morgan has a Buy rating on Gilead Sciences.
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Clovis Oncology Stock Rising Off Uptrend Channel Line

Clovis Oncology stock is rising off its uptrend channel line as large players volume continues to rise. The uptrend is also supported by the Twiggs Money Flow which is slowly rising. I dipped my toe in the water and purchased a little bit of Clovis Oncology stock today.

Clovis Oncology News

Since the company reported earnings on August 2, 2017, Clovis Oncology shares have lost about -8%. Clovis reported a second-quarter 2017 loss of -$1.29 per share, which was narrower than the year-ago loss of -$2.07 per share. The reported loss was greater than analysts forecast of -$1.27.

Net product revenues, entirely from Rubraca, were approximately $14.6 million in the quarter, up 108.6% sequentially. Revenues beat the consensus estimate of $12.54 million. The company said that 750 new patients were registered in the quarter.

Clovis Oncology’s Rubraca has shown an impressive growth trend in 2017. The drug received accelerated approval in Dec 2016. Rubraca is a PARP inhibitor, which is approved as a monotherapy for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. Rubraca has had an almost 100% growth in sales sequentially in the second quarter of 2017. Rubraca sales were $21.7 million in the first half of 2017. The company had 1100 new patients on therapy in the period.

Two confirmatory studies – ARIEL-3 and ARIEL-4 – are being conducted by Clovis for converting the accelerated approval to continued approval of Rubraca. The company’s shares got a boost when it announced positive top-line results from ARIEL 3 in June 2017. Progression-free survival (PFS) and safety results from the ARIEL-3 study demonstrated that Rubraca had a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. Clovis is planning to file a supplemental new drug application (sNDA) to the FDA by October this year based on ARIEL-3 data to include second-line or later maintenance indication for advanced ovarian cancer on the label of Rubraca. The company expects the label expansion to increase patient population by at least four times.

Rubraca is under review in the EU for a comparable ovarian cancer indication. An approval is expected from the EU in the first quarter of 2018.

I’m hearing rumors circulating that Clovis Oncology could be a takeover candidate by the end of the year because of Rubraca and the fact that Gilead bought KITE at the end of August.

You can find out more about Clovis Oncology here.

Clovis Oncology Stock Price

Clovis Oncology stock

Clovis Oncology stock usually swings higher at this time of year according to a seasonality study. Clovis Oncology stock is rising nicely off its uptrend line. The Effective Volume study shows large players volume rising. The Twiggs Money Flow is also rising which supports the thesis that large players are accumulating Clovis Oncology stock. I explain a lot of these chart patterns on the Frequently Asked Questions page here.

CLVS does present a good setup opportunity. Prices have been consolidating lately. There is a support zone below the current price at $72.66, a stop order could be placed below this zone.

BiondVax Pharmaceuticals Universal Flu Vaccine

Prepare to have your mind blown. A tiny little company called BiondVax Pharmaceuticals claims to have a flu immunization shot which will protect against future flu strains that don’t even exist yet! Sounds crazy but if this company really has produced a next generation flu shot capable of being a universal flu vaccine, the stock in this company is going to explode higher.

Flu vaccines are a $4.3 billion market. Current flu vaccines are limited to just 3 or 4 existing strains. Furthermore, seasonal flu vaccine effectiveness is only about 40% on average and as low as 9% in the elderly who are the most at risk group. Conversely, as a universal flu vaccine candidate, M-001 from BiondVax Pharmaceuticals is designed to provide improved and broad protection against all current and future seasonal and pandemic flu strains. The company published a paper in the journal Vaccine on their universal flu vaccine candidate M-001 where they showed the results of an immunization with M-001 prior to trivalent influenza vaccine in 2011-2012 and how it enhanced a protective immune responses against the 2014-2015 epidemic strain.

The Vaccine article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed significantly increased protective antibodies against the new epidemic 2014-2015 flu strain, a strain which did not exist when M-001 was administered to the BVX-005 participants!

BiondVax Pharmaceuticals Stock Chart

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… AWESOME TOOL

Adamis Pharmaceuticals Gets FDA Approval, Stock Explodes Higher!

Trader alert: Adamis Pharmaceuticals explodes higher on FDA approval of Epinephrine injection. Adamis Pharma announces FDA approval of its EPINEPHRINE INJECTION for the emergency treatment of allergic reactions (Type I) including anaphylaxis; anticipates launching in the back half of the year.

This will be a low cost alternative to Mylan’s EpiPen. The epinephrine-products market generated about $1.2 billion in sales last year so this is big news folks. This little pharmaceutical company could explode higher over the coming year.

Adamis Pharmaceuticals said, “With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market. We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”

Founded in 2006 and headquartered in San Diego, Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company that provides high quality, low-cost solutions for patients, physicians, and healthcare organizations in the multi-billion dollar therapeutic areas of respiratory disease and allergies. Adamis Pharmaceuticals lead pipeline product is an epinephrine injection pre-filled syringe product for potential use in the emergency treatment of anaphylaxis. Adamis is also currently developing other specialty pharmaceutical product candidates including APC-1000, an HFA inhaled nasal steroid product for the potential treatment of asthma; APC-2000, albuterol with a dry powder inhaler (DPI) propellant for the potential treatment of bronchospasms, and APC-4000, fluticasone with a DPI propellant for the potential treatment of asthma. With the rising costs of healthcare in recent years, Adamis has been focusing on creating low-cost therapeutic alternatives in large markets in order to grow its business and to make treatments more affordable for more people. Adamis will pursue the 505(b)(2) regulatory approval filings with the FDA whenever possible in order to minimize costs and shorten the time to market. With its lead pipeline product and specialty pharmaceutical pipeline, ADMP is poised to become a leader in the specialty biopharmaceutical industry.

Adamis Pharmaceuticals Stock Chart

ADMP presents a decent setup pattern. Prices have been consolidating lately. There is a very little resistance above the current price. We notice that large players showed an interest for ADMP in the last couple of days, which is a good sign.

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… AWESOME TOOL

Sell Portola Pharmaceuticals For a 45% Win!

April 10, 2017: Sell Portola Pharmaceuticals for a 45% win and congratulations if you made money on the trade.

December 27, 2016: Portola Pharmaceuticals price target raised to $29 from $20 at Credit Suisse, reiterates Neutral rating.

December 26, 2016: Biotechnology firm Portola Pharmaceuticals had revenue of $12.1 million in 2015. For 2016, revenue is on track to more than double to $26.2 million.

December 23, 2016: Portola Pharmaceuticals reports that the FDA accepts NDA for priority review for betrixaban, a prophylaxis of venous thromboembolism (VTE) Granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. A priority review shortens the FDA review timeline to six months from the standard review period of 10 months. The application for betrixaban, an FDA-designated Fast Track investigational drug, was deemed sufficiently complete to permit a substantive review and has been given a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017. Additionally, Portola announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE. The EMAs Committee for Medicinal Products for Human Use (CHMP) is reviewing the application under a standard 210-day review period.

December 19, 2016: Portola Pharmaceuticals announced it had signed a $50 million loan agreement with Bristol-Myers Squibb Company and Pfizer Inc. that provides additional funding toward development and clinical studies of AndexXa (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors. Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses.

December 15, 2016: Heavy call activity detected in Portola Pharmaceuticals of 1500 Jan 20 calls traded at $1.15.

Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases.

Jazz Pharmaceuticals Announces Positive Results From Phase 3 TONES 3 and TONES 4

March 20, 2017: Jazz Pharmaceuticals announced positive efficacy results from two global multicenter studies in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA). JZP-110 demonstrated highly statistically significant differences in the co-primary efficacy endpoints in the TONES 3 study at the 300 mg, 150 mg, 75 mg and 37.5 mg dose arms and in the TONES 4 study in the combined JZP-110 treatment arm (300 mg, 150 mg, and 75 mg doses) compared to placebo. Based on the preliminary safety analysis, the most commonly reported adverse events (AEs) in these studies were consistent with those previously described in the Phase 2 clinical studies evaluating JZP-110 in narcolepsy.

The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program is comprised of four studies, two in OSA, one in narcolepsy and one open-label, long-term safety and maintenance of efficacy study. The two Phase 3 OSA studies enrolled 652 total patients.
Efficacy Results of TONES 3 Study The TONES 3 study, or 14-003, is a 5-arm, parallel-group study evaluating four doses of JZP-110 (300 mg, 150 mg, 75 mg and 37.5 mg) and placebo for a 12-week period. The study enrolled 476 patients and was powered to detect differences between placebo and the 300 mg and 150 mg dose arms.

In TONES 3, JZP-110 demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test (MWT) and Epworth Sleepiness scale (ESS) at all doses. In addition, the key secondary endpoint of Patient Global Impression of Change (PGIc) scale demonstrated a highly statistically significant improvement in the 300 mg, 150 mg and 75 mg doses versus placebo. On the co-primary endpoints of MWT and ESS, the study demonstrated that treatment with JZP-110 significantly increased the patients’ ability to stay awake and significantly decreased patients’ subjective levels of sleepiness, respectively, compared to placebo. These effects were maintained throughout the course of the study.
Efficacy Results of TONES 4 Study The TONES 4 study, or 14-004, is a six-week study in which eligible subjects received four weeks of open-label treatment, and at the end of week 4, 126 patients who reported “much” or “very much” improvement on the PGIc scale and who had numerical improvements on the MWT and ESS at week 4 were then randomized 1:1 to receive either the same dose of JZP-110 received in the stable dose phase, or placebo, for two weeks in the randomized withdrawal phase.

In TONES 4, patients randomized to continue on JZP-110 maintained efficacy, while those randomized to placebo experienced a loss of efficacy, as measured by the co-primary and key secondary endpoints.

Preliminary Safety Results of TONES 3 and TONES 4 Studies Based on a preliminary safety analysis, the most commonly reported adverse events were headache, nausea, decreased appetite, dry mouth, anxiety, dizziness, insomnia, nasopharyngitis, and palpitations. There were six patients with serious adverse events (SAEs), two patients on placebo and four on JZP-110. None of these was deemed a treatment-related adverse event as assessed by the investigators. Additional safety information will be available based on the final analyses of the JZP-110 program, including results of the open-label, long-term safety and maintenance of efficacy study.

January 18, 2017: Leerink reiterates their Outperform rating on Jazz Pharmaceuticals and sets a price target of $182 after yesterday evenings FDA updates regarding a generic Xyrem (naracolepsy) application appear to be a net-positive for JAZZ as the FDA concurrently ruled (in a citizens petition [CP]) that it won’t allow generic substitutes to carve-out safety/dosing language that is patent protected. At a minimum, firm expects the approved generic will need to successfully litigate the Xyrem formulation (ends mid-2020E) and DDI patents (expires 2033E) before launching as they believe an at-risk launch against two battletested patent families would be financial catastrophic. Ultimately, todays update provides much needed visibility into how the FDA views the safety risk of omitting divalproex DDI (drug-drug interaction) and dosing language from the Xyrem package insert. Some investors believed generic companies’ ability to “carve out” the DDI information from their labels would allow them to argue they didn’t infringe the DDI patents. Based on last night’s ruling, it would appear this generic noninfringement strategy on the DDI patents is foreclosed. Further, with JAZZs DDI patents withstanding the invalidity challenge in multiple inter partes reviews (IPR) relating to the obviousness of those patents, those patents now appear much stronger and likely to withstand two central arguments they’d anticipate when the patent dispute moves to the district court in May 2017 (lead case). Based on the above considerations, firm believes the generic companies will be more likely to accept JAZZ’s likely settlement offer to launch in late 2025E since the risk of getting blocked until 2033E looks increasingly probable.

January 17, 2017: The U.S. Food and Drug Administration (FDA) has approved Jazz’s Xyrem, the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with narcolepsy have cataplexy. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy.

The use of Xyrem has been associated with serious side effects including seizures, trouble breathing, changes in alertness, coma, and death. Additionally, the active ingredient in Xyrem (and in the newly approved generic) is sodium oxybate. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). GHB has not been approved for any medical use and has the potential for abuse, such as in cases of sexual assault.

Because of the potential risks associated with Xyrem, it is subject to strict safety controls on prescribing and dispensing under a program called a Risk Evaluation and Mitigation Strategy (REMS). FDAs approval of generic sodium oxybate is subject to a REMS with strict safety controls that are comparable to those currently required for Xyrem.

Specifically, under both the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense sodium oxybate. Sodium oxybate will not be available in retail pharmacies.

In approving this generic version of Xyrem, the FDA is maintaining strict safety requirements for sodium oxybate, while providing patients with access to a generic medication option for narcolepsy. Source: http://www.fda.gov/Drugs/DrugSafety/ucm537281.htm

January 9, 2017: At the JP Morgan conference, Jazz said it plans to expand via M&A and partnerships this year; Affirms FY16 $9.90-10.30 versus $10.02 estimate; Revenue $1.5 billion versus $1.49 billion estimates.

December 15, 2016: Cantor Fitzgerald initiates JAZZ with an Overweight rating and a price target of $187.

Jazz Pharmaceuticals plc is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing important products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.

As part of our unwavering commitment to improving patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development, and pursuing focused development of our pipeline of differentiated therapies.

Sell Global Blood Therapeutics For a Huge 91% Win!

March 4, 2017: Sell Global Blood Therapeutics for a monster 91% win in 41 days! Congratulations if you were able to make money on the trade.

January 4, 2017: JPMorgan Chase initiates coverage of biotechnology firm Global Blood Therapeutics with an Overweight rating and a price target of $25. JPMorgan thinks GBT440 is a promising wholly owned asset targeting a broad and underserved market, as such current levels could provide an attractive entry point despite the relative lack of critical upcoming data.

GBT440-001 is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study. This ongoing Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of GBT440 in both healthy subjects and adults with SCD. The study is being conducted in three parts: Part A (single dose administration), Part B (multiple dose administration, daily for 15 days in healthy subjects and 28 days in SCD patients) and Part C (multiple dose administration, daily for 90 days in SCD patients). Some patients in Part C have taken GBT440 for up to 6 months.

Results presented at ASH showed:

– All 41 SCD patients receiving GBT440 for up to six months have demonstrated a profound and durable reduction in hemolysis (red blood cell destruction) as assessed by hemoglobin, reticulocytes, and/or bilirubin.

– All patients taking GBT440 showed profound and durable reductions in irreversibly sickled cells compared with those taking a placebo.

Results from Part C (dosing for at least 90 days) demonstrate that among the 13 GBT440-treated patients:

– Patients treated with GBT440 for at least 90 days showed a clinically significant increase in hemoglobin (greater than 1 g/dL increase) compared with 14 placebo patients (46 percent vs. 0 percent; p=0.006).

Patients treated with GBT440 had a sustained reduction in irreversibly sickled cells compared with placebo-treated patients (-76.6 percent vs. +9.7 percent; p<0.001).- GBT440 was well tolerated up to six months of dosing. The most common treatment-related adverse events were Grade 1/2 headache and gastrointestinal disorders and occurred at similar rates in the placebo and GBT440 arms. There were no drug-related serious or severe adverse events. No sickle cell crises events occurred in study participants while on GBT440. Exercise testing data showed normal tissue oxygen delivery (no change in oxygen consumption compared to placebo).

– Absorption, Metabolism and Excretion of GBT440 a Novel Hemoglobin S (HbS) Polymerization Inhibitor for the Treatment of Sickle Cell Disease (SCD), in Healthy Male Subjects (Abstract #2487)

– Results of a study evaluating the pharmacokinetics, metabolism, and excretion of GBT440 given orally to healthy subjects showed that the drug was completely excreted from the body, with a half-life of approximately three days. This is much shorter than the lifespan of a red blood cell (about 120 days) of a healthy subject, suggesting that the binding of GBT440 to hemoglobin is a reversible process. The data also suggests that the pharmacokinetics of GBT440 are unlikely to be affected in patients with renal disorders.

Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need.

GBT440 is Global Blood Therapeutics leading drug candidate which targets the underlying mechanism of red blood cell sickling and offers the potential to treat sickle cell disease (SCD) rather than only its symptoms.

Orexigen Therapeutics Sell For 157% Win!

February 16, 2017: Sell Orexigen Therapeutics for a 157% win in 36 days! Congratulations if you were able to make money on this trade.

January 25, 2017: Orexigen Therapeutics announced that Laboratorios Farmaceuticos Rovi has launched Mysimba in Spain. Mysimba is approved by the European Medicines Agency for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to January 4, 2017: Orexigen Therapeutics, Inc. unveiled “Brains Behind Weight Loss,” a new, national direct-to-consumer advertising campaign demonstrating to patients how the brain plays an important role in weight loss. The campaign will underscore how CONTRAVE (naltrexone HCl/bupropion HCl), an FDA-approved prescription weight-loss medicine, is believed to work on two important areas of the brain the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings. (The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood). CONTRAVE is the number one prescribed weight loss brand in the United States.

The CONTRAVE campaign is Orexigen’s first collaboration with Young & Rubicam New York since being tapped as agency of record. Kicking off at the start of the season amidst New Year’s resolutions, the campaign emphasizes the strong connection between the brain and weight loss. The visually intriguing images feature real women who arrange themselves to simulate depictions of the human brain.

December 26, 2016: Orexigen Therapeutics recently announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Biologix FZCO, have executed a commercialization and distributorship agreement in the Middle East for Contrave (naltrexone HCl / bupropion HCl prolonged release) monotherapy for weight management in overweight or obese adult patients.

This agreement covers ten countries in the Middle East: Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Qatar, Bahrain, Lebanon, Jordan, Iraq, and Iran. Under the terms of the agreement, Biologix will be responsible for obtaining regulatory approvals and local product registrations in each of the ten countries and for all commercialization activities. Orexigen will supply Contrave to Biologix at an agreed transfer price. Biologix expects Contrave to be available for patients in some countries starting in the third quarter of 2017.

December 8, 2016: Orexigen Therapeutics announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Consilient Health Ltd. had executed a commercialization and distributorship agreement for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in the UK and Ireland. Mysimba is approved by the European Medicines Agency, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to November 16, 2016: Orexigen Therapeutics announces the presentation of data for OREX-1019, a preclinical candidate for treatment and management of drug addiction Announced the presentation of preclinical data for OREX-1019 (BU10119) at Neuroscience 2016, the 46th annual meeting of the Society of Neuroscience, being held this week in San Diego. OREX-1019 is being evaluated by Orexigen as a treatment for opioid and cocaine addiction and was exclusively licensed by the company in 2015. OREX-1019 is a member of an orvinol compound series developed by Dr. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom.The data presented this week, “A buprenorphine analog attenuates drug-primed and stress-induced cocaine reinstatement,” was assembled by a team of researchers led by Dr. John Traynor, Ph.D. of the University of Michigan. The biochemical profile of several members of the licensed orvinol compound series, including OREX-1019, demonstrates reduced Mu opioid receptor activity compared to buprenorphine. The presented data provide in vivo evidence for the compound’s therapeutic potential in drug addiction management and suggest a wider use in cocaine addiction.

November 8, 2016: Orexigen Therapeutics announces commercialization and distributorship agreement with Valeant for Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand Announced that Valeant Pharmaceuticals International, Inc. (Valeant), through a wholly-owned subsidiary, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand. Under the terms of the agreement between Valeant and Orexigen’s wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining regulatory approvals and for all commercialization activities. Orexigen will supply Contrave tablets to Valeant for an agreed transfer price and certain potential sales milestone payments. Orexigen expects Valeant to file for regulatory approvals in both countries in the first half of 2017.

Orexigen and Valeant Pharmaceuticals International, Inc. previously announced commercialization agreements for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in 20 countries in Central and Eastern Europe and Contrave in Canada and South Africa.

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization.

ARIAD Pharmaceuticals Sell For 86.7% Win!

January 9, 2017: Sell ARIAD Pharmaceuticals on the news that it will be acquired by Takeda for $24 per share. This was a monster 86.7% win for us. Congratulations if you were able to make money on the trade.

January 4, 2017: Seeing heavy weekly call activity in Ariad Pharmaceuticals: 1,684 Jan 13 $13 calls trade at $0.40

December 7, 2016: ARIAD Pharmaceuticals announced that the investigational medicine brigatinib demonstrated 15.6 month systemic median progression-free survival in ALTA Study. The clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in ALK-positive (ALK+) non-small cell lung cancer (NSCLC) patients who had experienced disease progression on crizotinib therapy. As of May 31, 2016, the data show that of patients on the 180-mg regimen with a median follow-up of 11 months, 55% achieved confirmed objective response as assessed by the investigator. In this arm, the median progression-free survival (PFS) was 15.6 months in this post-crizotinib setting, by both investigator and independent review committee (IRC) assessment. Additionally, in this arm, 67 percent of patients with measurable brain metastases achieved a confirmed intracranial objective response, and intracranial PFS was 18.4 months among patients with any brain metastases at baseline. These data will be presented today at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) being held in Vienna.

The ALTA Trial

The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on their most recent crizotinib therapy. Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD, preceded by a lead-in dose of 90 mg QD for seven days (Arm B). Also, patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib therapy.

The primary endpoint of the ALTA trial is investigator-assessed confirmed objective response rate (ORR) as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Key secondary endpoints include PFS, confirmed ORR assessed by an IRC, overall survival (OS), CNS response and PFS, duration of response, safety and tolerability.

Key Data from the ALTA Trial UpdateBrigatinib Efficacy and Safety in ALK+ NSCLC Patients:

A total of 222 patients with ALK+ NSCLC treated with prior crizotinib therapy were randomized in the study (110 patients in Arm B at the 180-mg dose level with a seven-day lead-in at 90 mg and 112 patients in Arm A at the 90-mg dose level). The last patient was enrolled in the study in September 2015.

The median follow-up was 11 months in Arm B and 10.2 months in Arm A. ALTA trial data presented at the 2016 American Society of Clinical Oncology (ASCO) meeting, as of February 29, 2016, had median follow-up of 8.3 months in Arm B and 7.8 months in Arm A.Investigator-assessed confirmed ORR in Arm B was 55 percent. IRC-assessed confirmed ORR in Arm B was 54 percent. Investigator-assessed confirmed ORR in Arm A was 45 percent. IRC-assessed confirmed ORR in Arm A was 49 percent.

In a subgroup analysis of confirmed ORR by baseline characteristics, there was no difference in confirmed ORR based on prior chemotherapy versus no prior chemotherapy.

The subgroup analysis by best response to prior crizotinib (partial or complete response versus other) suggests that patients who had achieved partial or complete responses to prior crizotinib treatment had a significantly higher confirmed ORR, compared with patients who did not reach these reactions.

Responses in Arm B included a confirmed partial response in a patient with the ALK kinase domain G1202R mutation at baseline, which is associated with resistance to all approved tyrosine kinase inhibitors (TKIs).

Median PFS was 15.6 months by both investigator assessment and IRC assessment in Arm B. Median PFS was 8.8 months by investigator assessment and 9.2 months by IRC assessment in Arm A.

The probability of OS at one year was 82 percent and 71 percent in Arm B and Arm A, respectively. The median OS had not been reached in either arm.Of the 44 patients with measurable intracranial brain metastases at baseline, the IRC-assessed intracranial ORR was 67 percent (12/18) in Arm B and 46 percent (12/26) in Arm A.

The median IRC-assessed intracranial PFS was 18.4 months in Arm B and 15.6 months in Arm A.The most common treatment-emergent adverse events (TEAEs; = 30% of all patients, [Arm B/A]), regardless of relationship to treatment, were nausea (43%/36%), diarrhea (39%/21%), cough (36%/23%), headache (30%/28%) and increased blood creatine phosphokinase (CPK) (33%/11%).TEAEs, grade =3, occurring in =4 percent of all patients (excluding neoplasm progression; Arm B/A), were increased CPK (10%/3%), hypertension (6%/6%), pneumonia (5%/3%) and increased lipase (3%/5%).

A subset of pulmonary adverse events (AEs) with early onset (median: Day 2; range: Day 1-9) occurred in six percent of all patients (grade =3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.

Discontinuations and dose reductions due to AEs (Arm B/A) were 10 percent/three percent and 23 percent/eight percent, respectively. Discontinuations due to documented progressive disease (Arm B/A) were 23 percent and 30 percent.

The company said, “We are encouraged by the maturing efficacy and safety profile of brigatinib in this later data cut, which adds three months of follow up compared to the data presented at ASCO. These data are intended to be submitted to the European Medicines Agency in early 2017 for marketing approval. Pending regulatory review, we expect that brigatinib may become an important therapeutic option for the crizotinib-resistant population.”

November 29, 2016: ARIAD Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDAs accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drugs clinical benefit. The therapy was granted the FDAs orphan drug designation because it is intended to treat a rare disease or condition.

This full approval and label update is based on 48-month follow-up data (as of August 2015) from the pivotal Phase 2 PACE clinical trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. These data were presented at the 2016 meetings of the American Society for Clinical Oncology and the European Hematology Association (EHA).

About Iclusig(ponatinib) Tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.

In the U.S., Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.

November 7, 2016: ARIAD Pharmaceuticals beat on EPS, reporting Q3 EPS of -$0.12 versus the -$0.19 estimate. Revenue also beat coming in at $46 million versus the $41.9 million estimate.

– Affirming FY16 guidance for global Iclusig net product and royalty revenue of $170 million to $180 million.

– Affirming FY16 guidance for research and development expense of $175 million to $180 million, and sales, general and administration expense of $120 million to $125 million.

– Affirming FY16 guidance for cash, cash equivalents, and marketable securities at December 31, 2016, of $280 million to $290 million.

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines.

Biotechnology Won Big On Election Night Here’s Why

Hillary Clinton and Democrats promised to wage war on pharmaceutical companies and do things like price controls on drugs and products of the biotechnology industry.

In California, there was a ballot measure to impose price controls on the sale of pharmaceutical drugs in the state.

Both Hillary Clinton’s probability of winning, and California’s ballot measure to impose price controls on the sale of drugs, weighed on pharmaceutical and biotechnology stocks leading up to the election.

Donald Trump did not promise a war on pharma. Trump promised increased funding for research and development and modernizing the FDA to ease the development, commercialization, and costs of bringing life-saving drugs to market.

Donald Trump won, and biotech stocks have been rallying ever since.

Democrats created shortages in the health care industry with ObamaCare, and they almost created the same shortages in pharmaceutical drugs. Let’s look at why price controls create market shortages.

Price Control

A price control (or a price ceiling) occurs when the government puts a legal limit on how high the price of a product can be. For a price control to be effective, it must be set below the natural market equilibrium.

Using a hypothetical perfectly competitive market called pharmaceutical drugs, let’s examine the microeconomics of price control.

When a price control or price ceiling is set, a shortage occurs. The red horizontal line markets the price ceiling that is set by the government.

The price control forces the price down from P to P2. At the lower price, more people can afford the drug and so the quantity of the drug demanded goes up from Q to Q2 (point A).

The suppliers of the drug (pharmaceutical company) immediately cut back on supply (point B) as they are now paid below what the equilibrium market price established. Instead, these suppliers focus on supplying most of their drugs to other consumers, perhaps in other states that pay the full market price for the drugs they make. A shortage is created by the difference in the quantities of drugs demanded, versus the quantities of drugs supplied as illustrated by the shaded area. Shortages within the pharmaceutical industry would likely result in deaths, depending on the drugs needed.

The government set a price ceiling of P2 and so quantity supplied contracted to point B. However, at that supply level, consumers would be willing to pay a price of P3. Since P3 is greater than P2, deadweight loss occurs. The deadweight loss is the elimination of trading between both suppliers and consumers.

Price controls are a bad idea. If the government sets a price ceiling, there will be a shortage.