Wells Fargo Raised Microsemi To Outperform

January 31, 2016: Wells Fargo raised Microsemi to an Outperform rating, from Market Perform, and set a price target of $34 to $40. Wells Fargo analyst thinks PMC-Sierra acquisition is a sizeable one and a substantial opportunity for MSCC to realize additional share value and earnings growth.

More Microsemi News

January 13, 2016: Suntrust initiates coverage of Microsemi with a Buy rating, and a price target of $49.

December 16, 2015: Microsemi has commenced an exchange offer for all of the outstanding shares of PMC-Sierra, pursuant to their previously announced merger agreement, dated November 24, 2015. Subject to the terms and conditions of the Offer, PMC-Sierra stockholders who validly tender their shares in the Offer will receive $9.22 in cash and 0.0771 of a share of Microsemi common stock for each share of PMC common stock.

The Offer is scheduled to expire at 12:00 midnight, New York City time, at the end of January 14, 2016, unless earlier extended or terminated. The terms and conditions of the Offer are described in the exchange offer documents, which will be mailed to PMC stockholders and filed with the SEC.

Upon satisfaction of the conditions to the Offer, and after the shares tendered in the Offer are accepted for payment, Microsemi and PMC intend, as promptly as practicable, to effect a merger pursuant to Section 251(h) of the Delaware General Corporation Law, which would not require a vote of PMC’s stockholders, and which would result in each outstanding share of PMC common stock not tendered in the Offer (other than shares held by PMC in treasury, by Microsemi or its subsidiaries or by PMC stockholders who have validly exercised their appraisal rights under Delaware law) being converted into the right to receive $9.22 in cash and 0.0771 of a share of Microsemi common stock. The Offer is subject to customary conditions, including the tender of a number of shares of PMC common stock that together with any shares already held by Microsemi, equal to at least a majority of the outstanding shares of PMC’s common stock and certain regulatory clearances, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. No approval of the stockholders of Microsemi is required in connection with the proposed transaction. The board of directors of PMC recommends that PMC stockholders accept the Offer and tender their shares of PMC common stock to Microsemi pursuant to the Offer.

Microsemi Corporation (MSCC Updated Trend Analysis) makes analog and mixed-signal semiconductor solutions in the United States, Europe, and Asia.

MicrosemiCorp published this video about their VSWR products:

Hearing Chatter FCC Will Overhaul TV Set-top Box Regulations

Hearing rumors circulating that the FCC is set to overhaul TV set-top box regulations to help viewers access more internet content. This will be a boom for Internet content providers. It should also help increase the demand for bandwidth and thus help internet back-haulers and tower companies.

The regulatory changes would force cable and satellite providers to broaden support for third-party set-top boxes, paving the way for companies like Netflix, Google, and Apple to build new experiences on top of traditional cable services.

The changes would also create a new industry around third party set-top boxes that are created by neutral, non-television provider companies. Consumers will benefit in that instead of being forced to rent or purchase a set-top box from their television provider, consumers would be free to choose any unit designed to industry specifications.

Durable Goods Plunges Revisions Down Big

Durable Goods orders plunged in December 2015. The consensus range was -3% to +1.5%. The actual number was -5.1% meaning it was a surprise to the downside.

Core capital goods, which exclude defense equipment and aircraft, fell off a cliff at -4.3%.

Downward revisions were nasty as well. November was originally reported as -0.4%. It has now been revised down to -1.1%. That’s nearly a 200% larger drop than originally reported.

Other readings include a -2.2% monthly drop in total shipments and a -0.5% drop in total unfilled orders. This helped push inventories up +0.5% to raise the inventory-to-shipments ratio sharply, to 1.69 from 1.64. The rise in inventories is a headwind to the sector and will dampen future shipments as well as employment and this is what the Federal Reserve warned about in yesterday’s FOMC statement.

The factory sector has been in trouble from the rising US dollar. We saw this in the Empire State and ISM Manufacturing report. The rising US dollar together with contraction in the energy sector may now be pushing the factory sector into an accelerated crash, at least that’s the concern among traders that I’m hearing.

Surpise Shocker, Home Sales Surge To the Upside

New home sales surprised to the upside, coming in at 544K.

The spin by the real estate industry in the mainstream financial media is that this report bodes well for 2016 and future home sales. I disagree with that analysis.

We know from the Retail Sales report that consumers are broke and no one has any money as wages have been flat and rising healthcare costs have taken away any benefit that low oil and gas prices have provided to the consumer.

The other spin that real estate professionals are putting forth is that low supply is what is holding back sales. That’s an absurd point. Go back and take a macroeconomics course on supply and demand. It’s movement along the demand curve that primarily drives sales and supply, not the supply curve. In very unusual, external events that impact supply, ie supply shocks, yes, they do impact price but that’s not what we currently have happening.

So why are new home sales moving higher?

Professional investment groups and foreigners are the primary buyers of new homes and they are doing this because the Federal Reserve has put us into a rising rates environment. In other words, the price to finance a new home purchase is only going to rise from here and so you have this last push to purchase a home while finance costs are still this low.

What these investment groups are doing is that they know that most consumers don’t have any money so they will have to rent. They are purchasing new homes while the financing is cheap, then renting them out as demand for rentals explodes higher. They will use that rental home to generate cash-flow while they wait for home prices to rise in this rising rates environment. When home prices eventually do, they’ll sell the home and make a windfall.

Do not get me wrong, I’m not a perma-bear. This is just a theory of mine right now based on other economic reports I track for you each month. Think about it. Nobody has any money as evidenced by the drop in the price of oil not even helping retail sales, but boy they sure do have enough money to buy a new home? That doesn’t make any sense.

It is a grand-unified theory and view that is consistent with other economic reports that show the economy is drastically slowing. Remember folks, when you see monthly economic reports that seem to contradict each other, most often they really don’t. Instead, it’s your own interpretation that needs modifying. Zoom-out on your economic analysis and search for a theory that unifies all the reports, and your forecasting will improve. Now with that said, everything I just told you could be wrong. As you probably know, economic forecasting is a lot like weather forecasting. Enough said.

Here is an updated new home sales chart:

Korea Electric Power Demand Hits All-time High On Cold Weather

January 25, 2016: Korea Electric Power Co. moved higher today after Hana Financial released a positive broker note. Hana Financial is one of the largest bank holding companies in Korea.

More Korea Electric Power News

January 19, 2016: Korea Electric Power Co. reports in Korean press say South Korea’s power demand hit all-time high this week of 82.1M kw due to severe cold wave. The average temperature fell to -10 degrees Celsius.

January 18, 2016: The Korean press reports that Korea Electric Power Corp. has been awarded a substation construction deal with Bhutan with an estimated value of $25.6 million.

December 20, 2016: Moody’s revises Korea Electric Power outlook to stable. Moody’s analyst says, “The rating upgrade for KEPCO reflects Moody’s recognition that the Korean government’s own improving credit profile will benefit the company’s credit quality, given the very high likelihood of the government’s timely support to the company, if and when needed.” Moody’s thinks that KEPCO’s credit quality will remain closely linked to that of the government, because of its high strategic importance and strong policy functions for Korea’s power sector.

Korea Electric Power Corporation (KEP Updated Trend Analysis) is an electric utility company that generates, transmits, and distributes electricity in Korea and internationally. The company operates through Transmission and Distribution, Electric Power Generation (Nuclear), Electric Power Generation (Non-Nuclear), Plant Maintenance & Engineering Service, and Others segments.

IIMTnew published this video about Korea Electric Power:

Johnson Controls Confirms Merger With Tyco

January 25, 2016: Johnson Controls Inc confirms merger with Tyco but stock dumps on the news as traders expected a better deal. I will discontinue tracking of Johnson Controls. The details of the merger are as follows. JCI holders to receive one Tyco share or $34.88/shr cash, Tyco holders to receive 0.9550 shares per share. Under the terms of the agreement, which has been unanimously approved by both companies’ Boards of Directors, Johnson Controls shareholders will own approximately 56% of the equity of the combined company and receive aggregate cash consideration of approximately $3.9 billion. Current Tyco shareholders will own approximately 44% of the equity of the combined company.

Immediately prior to the merger, Tyco will effect a reverse stock split so that Tyco shareholders will receive a fixed exchange ratio of 0.9550 shares for each of their existing Tyco shares. Johnson Controls shareholders may elect to receive either one share of the combined company for each of their Johnson Controls shares or cash equal to $34.88 per share, which represents Johnson Controls’ five-day volume-weighted average share price. Elections by Johnson Controls shareholders are subject to proration such that an aggregate of approximately $3.9 billion cash is paid in the merger.

Under the terms of the proposed transaction, the businesses of Johnson Controls and Tyco will be combined under Tyco International plc, which will be renamed “Johnson Controls plc.” The companies expect that shares of the combined company will be listed on the New York Stock Exchange and trade under the “JCI” ticker. Upon the closing of the transaction, the combined company is expected to maintain Tyco’s Irish legal domicile and global headquarters in Cork, Ireland. The primary operational headquarters in North America for the combined company will be in Milwaukee, where Johnson Controls has been based.

The combination will be tax-free to Tyco shareholders, and taxable to Johnson Controls shareholders. Tyco has secured a committed $4.0 billion bank facility to finance the cash consideration of the transaction. The completion of the transaction, which is expected by the end of fiscal year 2016, is subject to customary closing conditions, including regulatory approvals and approval by both Johnson Controls and Tyco shareholders.

The new company expects to deliver at least $500 million in operational synergies over the first three years after closing. These annual cost synergies are expected to be achieved by increasing efficiencies, eliminating redundancies, integrating the global branch networks, and leveraging the combined scale of an over $20 billion buildings business platform. In addition, the transaction is expected to create at least $150 million in annual tax synergies.

Johnson Controls announced in July 2015 that it is planning to spin off Adient at the beginning of fiscal year 2017. Both Johnson Controls and Tyco shareholders will receive shares of Adient (Johnson Controls Automotive Experience) which will be distributed after the merger. The Adient spin-off is expected to occur at the beginning of fiscal 2017.

Pro forma for the transaction and separation of Adient, Johnson Controls is expected to have approximately $32 billion of revenue in fiscal year 2016 and $4.5 billion of EBITDA before synergies. Adient is expected to have approximately $16.6 billion of revenue in fiscal year 2016 and $1.6 billion of EBITDA. In addition, Adient is expected to distribute between $2.5 to $3.5 billion to Johnson Controls in conjunction with the spin-off.

More Johnson Controls News

January 24, 2016: Hearing rumors circulating that Johnson Controls is in advanced talks with Tyco and that a merger deal could be announced as early as this week. Rumors say that Johnson Controls CEO Molinaroli is thought to be named CEO of combined companies.

Johnson Controls, Inc. operates as a diversified technology and industrial company worldwide with over 170,000 employees. The company creates products, services and solutions to optimize energy and operational efficiencies of buildings; lead-acid automotive batteries and advanced batteries for hybrid and electric vehicles; and interior systems for automobiles.

Johnson Controls published this video about their company:

TheStreet Calls Lululemon a Standout Stock To Buy

January 24, 2016: TheStreet calls Lululemon a standout stock to buy. TheStreet says the ability of Lululemon to drive a better-than-expected holiday season against a backdrop of overall tepid spending by consumers bodes well for its fortunes this spring. In effect, it offers a sign the company’s merchandise is resonating with finicky consumers. Source: http://www.thestreet.com/story/13431343/2/3-standout-retail-stocks-that-are-worth-buying-now.html

More Lululemon Athletica News

January 13, 2016: Wedbush reiterates Outperform rating on Lululemon Athletica Inc, and raises the price target to $65 from $56.

January 2, 2015: Hearing takeover rumors circulating about Lululemon and that V.F. Corp could be a potential suitor. Source of rumors likely coming from this article on TheStreet: http://www.thestreet.com/story/13409153/3/lululemon-gets-sold-and-2-other-bold-retail-predictions-for-2016.html

November 20, 2015: Lululemon Athletica Inc (LULU Updated Trend Analysis) hearing rumors circulating that say Nike may consider making a bid for LULU. LULU spokesperson says “no comment” on the report, notes the company is in a quiet period ahead of earnings which should be released around Dec 10th.

November 19, 2015: Lululemon Athletica hearing vague takeover rumors circulating. The rumor is that Under Armour is a potential acquirer with a buyout offer in the low $60’s.

Lululemon Athletica (LULU Updated Trend Analysis) makes athletic apparel and accessories for men, women, and young females. The company sells shorts, tops, pants, and jackets for healthy lifestyle activities and athletic pursuits, such as yoga, running, dance, and general fitness.

Hearing Chatter That Mobile Device Suppliers Will Lower Guidance

I’m hearing rumors that more mobile device suppliers will be cutting forward guidance estimates because of weakness in consumer demand in the mobile device market.

This rumor likely comes from the fact that three component suppliers for mobile devices, ADI, CRUS, and QRVO, have all cut their guidance last week on weakness in the mobile device market.

The rumor coincides with short-sellers that have been targeting Apple shares recently because of reports from component suppliers that indicate that sales of the iPhone 6s are not living up to expectations. Apple reports on smartphone sales on Tuesday, January 26, 2016, so we should know more then.

The Vanguard Information Technology ETF has long been considered by professional traders as one of the best ways to play the mobile device market. As such, it’s a good read on the entire mobile devices sector.

We could see short sellers target this ETF next week if Apple confirms the slow down we are already seeing in component suppliers for mobile devices.

Eli Lilly’s Humulin R U-500 KwikPen Gets FDA Approval

January 21, 2016: Eli Lilly and Co gets FDA approval of Humulin R U-500 KwikPen. The FDA approved HumulinR U-500 KwikPen (insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

More Eli Lilly News

December 28, 2015: Leerink reiterates an Outperform rating on Eli Lilly and Co, and raises its price target to $95 from $93.

December 10, 2015: Eli Lilly announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck’s KEYTRUDA(pembrolizumab) in a Phase I study across multiple tumor types. Based on the Phase I trial results, the collaboration has the potential to progress to Phase II trials in patients who have been diagnosed with either metastatic breast cancer or non-small cell lung cancer (NSCLC).

Lilly is the sponsor of the Phase I study, and of any subsequent Phase II studies, per the terms of the agreement. Enrollment is scheduled to begin in early 2016. Financial details of the collaboration were not disclosed.

Lilly’s abemaciclib is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK4 and CDK6. Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

November 30, 2015: Eli Lilly and Co (LLY Updated Trend Analysis) Boehringer Ingelheim Ltd. and Eli Lilly Canada announced today that Health Canada has approved JARDIANCE (empagliflozin) to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.

JARDIANCE belongs to a new class of agents called sodium glucose co-transporter 2 (SGLT2) inhibitors that have a different mechanism of action from other oral glucose-lowering agents. JARDIANCE lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

November 24, 2015: Eli Lilly and Co receives FDA approval for Portrazza (necitumumab) in advanced squamous non-small cell lung cancer. The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer squamous cell and non-squamous cell (which includes adenocarcinoma). The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open-label clinical study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without Portrazza. Those taking Portrazza plus gemcitabine and cisplatin lived longer on average (11.5 months) compared to those only taking gemcitabine and cisplatin (9.9 months). Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC. The most common side effects of Portrazza are skin rash and magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats and can be fatal. Portrazza includes a boxed warning to alert health care providers of serious risks of treatment with Portrazza, including cardiac arrest and sudden death, as well as hypomagnesemia.

November 24, 2015: Eli Lilly and Co FDA grants orphan designation for necitumumab for the treatment of squamous non-small cell lung cancer.

November 08, 2015: Eli Lilly and Co detailed results demonstrate Baricitinib superiority to Adalimumab in improving signs and Symptoms of rheumatoid arthritis. Eli Lilly and Company and Incyte Corporation today announced detailed data from pivotal phase 3 study RA-BEAM, the fourth successful phase 3 study of baricitinib, at the American College of heumatology/Association of Rheumatology Health Professionals annual meeting in San Francisco. The findings demonstrated statistical superiority for investigational therapy baricitinib over adalimumab (Humira(R) )* after 12 weeks based on several critical measures of rheumatoid arthritis (RA) disease activity, including ACR20, ACR50 and ACR70 response rates — composite scores that represent at least a 20%, 50% and 70% improvement in multiple components of RA disease activity.

November 08, 2015: Eli Lilly patients show significant improvement in signs and symptoms of Psoriatic Arthritis when Treated with Ixekizumab for 24 Weeks. Psoriatic arthritis (PsA) patients treated with ixekizumab for 24 weeks achieved significant improvements in signs and symptoms of their disease when compared to placebo, while also experiencing significantly less progression of radiographic structural joint damage, reduced disability when performing certain physical functions and improved skin clearance of plaque psoriasis.

Detailed results of the SPIRIT-P1 study were presented during the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco. Ixekizumab is the company’s investigational medicine for the treatment of active PsA and moderate-to-severe plaque psoriasis.

“The SPIRIT-P1 data show that ixekizumab may be able to address unmet or underserved needs that many patients living with psoriatic arthritis have, including the reduction of painful and debilitating skin and joint inflammation, which are the hallmarks of this chronic disease,” said Philip Mease, M.D., chief of rheumatology research, Swedish Medical Center, and clinical professor, University of Washington, Seattle. Dr. Mease is a SPIRIT-P1 study investigator.

During the 24-week, double-blind period of this Phase 3 study, patients who had never received a biologic disease-modifying antirheumatic drug (bDMARD) were treated with either 80 mg of ixekizumab once every two weeks or every four weeks (following a 160 mg starting dose); adalimumab at the approved dose of 40 mg every other week; or placebo. Adalimumab was employed as an active control in the SPIRIT-P1 study and was not powered for comparison with ixekizumab treatment groups.

Significant Improvements in Disease Signs and Symptoms, Structural Joint Damage
In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements compared with placebo in disease activity of PsA as demonstrated by the proportion of patients achieving an ACR20 response at 24 weeks, the study’s primary objective. Improvements were experienced by ixekizumab-treated patients as early as one week after treatment initiation. ACR20 represents at least a 20 percent reduction in a composite measure of disease activity as defined by the ACR. Other measures included ACR50 and ACR70, which represent 50 percent and 70 percent reductions in disease activity.

At 24 weeks, 62 percent of patients treated every two weeks and 58 percent of patients treated every four weeks with ixekizumab achieved ACR20 compared with 30 percent of placebo-treated patients. The proportions of ixekizumab-treated patients who achieved ACR50 when treated every two weeks or every four weeks were 47 percent and 40 percent, respectively, compared with 15 percent of patients treated with placebo. Furthermore, 34 percent of patients treated with ixekizumab every two weeks and 23 percent of those treated every four weeks experienced a 70 percent reduction in disease activity. Six percent of patients treated with placebo achieved this level of improvement.

Patients treated with ixekizumab at both dosing regimens also experienced significantly less radiographic progression of structural joint damage than those treated with placebo, as measured by the change from baseline in the van der Heijde modified total Sharp score (mTSS) for PsA at 24 weeks. Structural joint damage caused by PsA may lead to permanent joint deformity and reduced physical function.

Reduced Disability in Physical Function, Improved Skin Clearance
Ixekizumab treatment groups also experienced significant improvements compared with placebo in other key secondary measures, including physical function as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), and improved skin clearance of plaque psoriasis as measured by the Psoriasis Area and Severity Index (PASI), including PASI75, 90 and 100. A PASI75 score indicates at least a 75 percent reduction in a patient’s plaque psoriasis from the patient’s baseline assessment, while PASI90 reflects a 90 percent reduction and PASI100 represents a 100 percent reduction, reflecting complete skin clearance.

Efficacy results with adalimumab compared with placebo during the SPIRIT-P1 study were significant on most measures. At 24 weeks, 57 percent of patients treated with adalimumab, the study’s active control, achieved ACR20, while 39 percent and 26 percent achieved ACR50 and ACR70, respectively.

The incidence of treatment-emergent adverse events (TEAE) was greater with ixekizumab treatment compared with placebo. The most common (=4 percent) adverse events observed with ixekizumab treatment were injection site reaction, injection site erythema and nasopharyngitis. These events are consistent with those reported in the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (UNCOVER 1, 2, 3). Serious adverse events and discontinuation rates due to adverse events were not significantly different between treatment groups.

“Many people living with this debilitating disease are still searching for an effective treatment,” said J. Anthony Ware, M.D., senior vice president, product development, Lilly Bio-Medicines. “These results further support our continuing investigation of ixekizumab for the treatment of psoriatic arthritis, and our belief that this investigational medicine may offer a viable choice in the future for people seeking a better way to manage their disease.”

About the SPIRIT-P1 Study
SPIRIT-P1 is a Phase 3 randomized, active- and placebo-controlled study examining the effect of ixekizumab compared with placebo in patients with active PsA who are bDMARD-nave. Patients were required to have an established diagnosis of PsA and active disease for at least six months. The trial included 417 patients (stratified 1:1:1:1 ratio for all treatment groups) with active psoriatic arthritis who had at least three tender and three swollen joints and the presence of at least one disease-related joint erosion of the hand or foot as seen on X-ray or a C-reactive protein (CRP) greater than 6 mg/L at screening. During the study, ixekizumab-treated patients received a starting dose of 160 mg administered subcutaneously (SC), as two 80 mg injections, followed by one of two dosing regimens: either 80 mg administered SC once every two weeks or 80 mg administered SC once every four weeks. Adalimumab at the approved dose of 40 mg SC and regimen of every other week was selected as the active control for comparison with placebo. The SPIRIT-P1 study will also evaluate the long-term efficacy and safety of ixekizumab in PsA for up to three years.

October 22, 2015: Eli Lilly and Co (LLY Updated Trend Analysis) and AstraZeneca expand immuno-oncology research collaboration with new combinations. Eli Lilly and Company and AstraZeneca announced an extension to their existing immuno-oncology collaboration exploring novel combination therapies for the treatment of patients with solid tumors. Under the terms of the expanded agreement, Lilly and AstraZeneca will evaluate the safety and efficacy of a range of additional combinations across the companies’ complementary portfolios. Lilly will lead the execution of the studies, while both companies will contribute resources. Additional details of the collaboration, including tumors to be studied and financial terms, were not disclosed. AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system, including:
– TGF-beta kinase inhibitor, galunisertib.
– CXCR4 peptide antagonist.
– An anti-CSF-1R monoclonal antibody, which will also be assessed with AstraZeneca’s anti-CTLA-4 monoclonal antibody, tremelimumab.
The companies will also explore other combinations targeting tumor drivers and resistance mechanisms, including:
– Lilly’s abemaciclib (CDK4 and 6 small molecule inhibitor) with Faslodex, AstraZeneca’s marketed selective estrogen receptor down regulator (SERD).
– Both CYRAMZA() (ramucirumab) and necitumumab, Lilly’s anti-VEGFR and anti-EGFR monoclonal antibodies, respectively, with AZD9291, AstraZeneca’s investigational third-generation EGFR inhibitor.

October 11, 2015: Eli Lilly and Co Lilly and Innovent Biologics Expand Their Strategic Alliance to Include Immuno-Oncology Bispecific Antibodies in China and Globally. Eli Lilly and Company and Innovent Biologics, Inc. (Innovent) today announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company. Below are details of the expanded agreement:
– The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
– Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
– Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
– Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed.
Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.

October 12, 2015: Eli Lilly and Co to discontinue Phase 3 trial of evacetrapib due to insufficient efficacy; to take $0.05 charge in Q4. Eli Lilly has accepted the recommendation of the independent data monitoring committee to terminate the Phase 3 trial of the investigational medicine evacetrapib, due to insufficient efficacy. Lilly will discontinue development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease and will now conclude other studies in the program. The independent data monitoring committee based its recommendation on data from periodic data reviews, which suggested there was a low probability the study would achieve its primary endpoint based on results to date. The study is not being stopped for safety findings. After further analysis, results of the study will be presented in scientific forums in the future. “This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth,” said Derica Rice, Lilly executive vice president and chief financial officer. “Our recent string of positive data-readouts and our strong pipeline position us to grow revenue and expand margins through the remainder of this decade.” The decision to discontinue development of evacetrapib is expected to result in a fourth-quarter charge to research and development expense of up to $90 million (pre-tax), or approximately $0.05 per share (after-tax). The company will incorporate this estimated charge into its updated 2015 guidance that will be provided as part of its third quarter 2015 earnings press release on Thursday, Oct. 22, 2015.

October 8, 2915: Eli Lilly receives FDA Breakthrough Therapy Designation for Abemaciclib CDK 4 and 6 Inhibitor. The FDA has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

“If caught before it spreads, patients can survive breast cancer. However, for the nearly 10 percent of patients who are initially diagnosed at stage IV, and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease, there remains an urgent need for effective therapy options,” said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. “We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review.”

Lilly has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

Eli Lilly (LLY Updated Trend Analysis) is a global healthcare company that creates high-quality medicines that meet needs. It operates through two segments, Human Pharmaceutical Products and Animal Health Products. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.