Progenics up 6% on PyL data in prostate cancer

Progenics Pharmaceuticals (PGNX +5.9%) is up on below-average volume on the heels of results from a Phase 2/3 clinical trial, OSPREY, evaluating PSMA-targeted PET imaging agent PyL in men with high-risk metastatic prostate cancer and an investigator-sponsored study assessing PyL in men with biochemically recurrent prostate cancer. The data were presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Anaheim, CA.

The company says the collective data show PyL’s ability to detect locally advanced, biochemically recurrent and metastatic prostate cancer.

A Phase 3 study, CONDOR, is in process with an estimated completion date of January 2020.

https://seekingalpha.com/news/3473624-progenics-6-percent-pyl-data-prostate-cancer

VBI Vaccines down 12% ahead of corporate presentation

VBI Vaccines (VBIV -12.4%) is down on more than a 5x surge in volume ahead of a corporate presentation today at the BMO Capital Markets Healthcare Conference by President & CEO Jeff Baxter. He is scheduled to take the podium at 11:20 am ET.

https://seekingalpha.com/news/3473628-vbi-vaccines-12-percent-ahead-corporate-presentation

Pharma players in green on AbbVie/Allergan deal

Members of Big Biopharma, with the notable exception of AbbVie, are all enjoying a spike in buying after its $63B bid for Allergan, stoking hopes that big healthcare mergers are back in play.

Selected tickers: Takeda (TAK +1.3%), Bausch Health Companies (BHC+4.2%), Roche (OTCQX:RHHBY +0.2%), AstraZeneca (AZN +0.2%), Bristol-Myers Squibb (BMY +1%), GlaxoSmithKline (GSK +0.6%), Johnson & Johnson (JNJ +0.6%), Eli Lilly (LLY +0.7%), Merck (MRK), Novartis (NVS+0.7%), Pfizer (PFE +0.6%), Teva Pharmaceutical Industries (TEVA+6.4%), Amgen (AMGN +0.9%), Biogen (BIIB +3.1%), Gilead Sciences (GILD +1%), Vertex Pharmaceuticals (VRTX +0.3%)

ETFs: (XPH +3.4%), (XBI +0.9%), (IBB +0.9%), (PJP +1.2%), (IHE+2.3%), (PPH +0.6%), (XLV +0.1%)

https://seekingalpha.com/news/3473634-pharma-players-green-abbvie-allergan-deal

In state settlement, Teva agrees to stop marketing opioids in Oklahoma

Generic drug manufacturer Teva Pharmaceuticals USA has agreed not to promote opioids in any way in Oklahoma for more than 27 years as part of a settlement of the state’s lawsuit over the deadly opioid crisis.

The promotion ban was one of the key new details to emerge Monday when the settlement became public. The three-point ban will be in effect until Dec. 31, 2026.

As previously announced, Teva Pharmaceuticals USA and affiliated companies agreed in May to pay $85 million to be dropped from the lawsuit. The settlement was filed Monday after Cleveland County District Judge Thad Balkman signed off on it.

https://www.marketscreener.com/TEVA-PHARMACEUTICAL-INDUS-56537293/news/Teva-Pharmaceutical-Industries-As-part-of-settlement-with-state-Teva-Pharmaceuticals-agrees-to-st-28810624/

UnitedHealth Buys PatientsLikeMe After Forced Divestment of China Investment

UnitedHealth Group Inc. bought PatientsLikeMe, a company that helps connect people who have similar health conditions, after the startup was forced to divest an investment by a Chinese firm.

The company will become part of UnitedHealth’s research operation, according to an email PatientsLikeMe sent to customers. UnitedHealth Group is the parent of the largest U.S. health insurer, UnitedHealthcare, and a rapidly growing health-services arm called Optum.

The deal reflects the deep appetite for patient data in the health industry, with pharmaceutical and other life-sciences companies as well as insurers, technology companies and health-care providers all eager to tap new sources of information in developing treatments and ways to manage care.

PatientsLikeMe bills itself as the “world’s largest personalized health network,” and it says that more than 650,000 people with 2,900 conditions have helped generate data. The company calls its site “an unprecedented source of real-world evidence.”

The acquisition closed on June 19, according to the PatientsLikeMe email. Terms weren’t disclosed.

The sale to UnitedHealth came after an investment in PatientsLikeMe by Shenzhen-based digital health company iCarbonX, which is backed by Chinese internet giant Tencent Holdings Inc., came under scrutiny by the Committee on Foreign Investment in the U.S. Cfius, an interagency panel that vets foreign investments for security risks, demanded iCarbonX unwind its 2017 investment.

In the email to customers, PatientsLikeMe said it is “joining the research and development arm of UnitedHealth Group.” The company told customers that “there will be no transfer of your personal data inconsistent with the original consent, from the PatientsLikeMe’s secure database.”

The company also said it was “committed to using your data for good, protecting your data, and advancing our understanding of diseases through your partnership.”

“We look forward to collaborating on patient-first research and building upon the supportive communities patients have come to rely on,” a UnitedHealth spokesman said in a statement.

The deal was first reported by MobiHealthNews.

https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-Buys-PatientsLikeMe-After-Startup-Was-Forced-to-Divest-Chinese-Investment-28810858/

Conatus to Cut Staff by 40%, Consider Sale in Light of Recent Failures

San Diego-based Conatus Pharmaceuticals indicated that it is considering a sale of the company as part of an exploration of strategic alternatives. It is already implementing a restructuring plan that will cut 40% of staff and suspend development of its inflammasome compound CTS-2090.

The first big disappointment was in March, when its emricasan failed its Phase IIb ENCORE-NF clinical trial in patients with biopsy-confirmed nonalcoholic steatoheptitis (NASH) and liver fibrosis. NASH is a metabolic disease similar to cirrhosis of the liver, but it occurs in people who drink little or no alcohol. The company had been partnered with Novartis on developing the drug, and had received a $50 million payment in 2017 for worldwide rights to the drug.

Then on June 24, the company announced topline results from ENCORE-LF, indicating that it didn’t meet its primary endpoint and was ending further treatment of patients enrolled in the trial. Conatus also said that the data from the 24-week extension of its ENCORE-PH trial of the drug was consistent with data from the first 24-week period and didn’t meet predefined objectives.

“We designed the ENCORE program to give emricasan an opportunity to achieve its potential through a series of clinical trials tailored to specific patient populations encompassing a broad range of chronic liver disease,” stated Steven J. Mento, president, chief executive officer and co-founder of Conatus. “We are disappointed that emricasan failed to meet the expectations established in prior preclinical and clinical studies, but confident that the ENCORE trials provided a fair evaluation of emricasan’s lack of efficacy in these patient populations.”

Also, last year, the drug failed to stop or reverse damage to liver transplants caused by hepatitis C.

“We remain excited by the potential of CTS-2090 as a uniquely positioned inflammasome disease compound,” Mento said in today’s announcement. “However, we must preserve our remaining resources to extend our cash runway to better explore strategic alternatives that can benefit shareholders, Although we are halting development activities for CTS-2090, we plan to continue to explore a variety of opportunities to advance this compound.”

Conatus indicates it is projecting a 2019 year-end net balance of cash, cash equivalents and marketable securities between $10 million and $15 million.

Company shares plunged to about 30 centers per share from just under $1.00.

NASH, for which there are no approved treatments, is proving to be a tough nut to crack. Other notable drug failures have been Cymabay Therapeutics and Gilead Sciences.

That may be about to come to an end, though. Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) showed additional positive data from its REGENERATE Phase III trial in NASH in April. The drug was approved in May 2016 by the FDA for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or alone in adults unable to tolerate UDCA.

Intercept has indicated it plans to file with the FDA for NASH for the drug in the third quarter of this year.

And just yesterday, Genfit and Terns Pharmaceuticals inked a $228 million strategic partnership to develop Genfit’s elafabranor for NASH in China.

https://www.biospace.com/article/conatus-cuts-staff-by-40-percent-and-considers-sale-after-nash-failure/

AbbVie Makes ‘Transformational’ Move with $63 Billion Acquisition of Allergan

This morning, Illinois-based AbbVie announced it will acquire Ireland-based Allergan for $63 billion in a cash and stock deal. The acquisition is expected to be “transformational” for both companies, AbbVie said.

Richard Gonzales, chairman and chief executive officer of AbbVie, said the acquisition of Allergan achieves “unique and complementary strategic objectives” for both companies. In a statement outlining AbbVie’s proposal, Gonzales said combining the two companies will allow AbbVie to diversify is business, while “sustaining our focus” on scientific research and the company’s pipeline, which includes the top-selling drug, Humira.

In its announcement, AbbVie noted that a deal this size, in comparison to smaller “bolt-on” deals, is designed to deliver immediate scale to the company’s growth platform and also meets its strategic goal to reduce reliance on Humira, which has been the primary cash cow of the company.

“Smaller bolt-on acquisitions provide opportunities for future growth, but also require significant R&D investment amid scientific and clinical uncertainty. This transaction offers immediate compelling financial and strategic value to our shareholders with a much lower risk profile,” AbbVie said.

For Allergan, which includes the tent-pole of Botox and a strong migraine treatment pipeline, an acquisition has been years in the making. At one time, Allergan was a target for acquisition by Pfizer. However, that deal was called off due to the implementation of new regulations from the U.S. Department of Treasury regarding tax inversions. Since the 2016 termination of that deal, Allergan has repeatedly been rumored to be the target for acquisition, particularly as its stock slipped for several quarters in 2018, in large part due to generic competition in the U.S. As a result, some shareholders have called for changes to its board of directors.

Brent Saunders, chairman and CEO of Allergan, said the acquisition will lead to a company with combined revenue of approximately $48 billion this year. The combined companies generated $19 billion in operating cash flow in 2018. The two companies will have a strong pipeline in multiple therapeutic areas and “robust cash flows.” Saunders also said the combined companies will be able to make larger contributions to global health than either company could on their own.

“Our fast-growing therapeutic areas, including our world-class medical aesthetics, eye care, CNS and gastrointestinal businesses, will enhance AbbVie’s strong growth platform and create substantial value for shareholders of both companies,” Saunders said in a statement.

AbbVie said the combined companies will have several strong franchises across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology. Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise and international infrastructure, the company said.

AbbVie also noted that the acquisition of Allergan will benefit shareholders through significant cash flow generation and said the deal is expected to be 10% accretive to adjusted earnings per share over the first full year following the close of the transaction, At peak, Allergan said accretion could be greater than 20%. AbbVie’s enhanced growth platform is expected to grow at a high-single-digit annual growth rate well into the next decade, from more than $30 billion in 2020, the company added.

Unlike the proposed Pfizer deal that would have seen that company move its headquarters to the U.K. for tax benefits, the combined AbbVie and Allergan will maintain principal executive offices in North Chicago, Ill. Gonzales will continue to helm AbbVie as chairman and CEO. Two members of Allergan’s Board, including Saunders, will join AbbVie’s Board upon completion of the transaction.

Under the financial nuts and bolts of the deal, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share they hold. That will provide a total value of $188.24 per share of Allergan. When the deal is finalized, AbbVie shareholders are expected to have an 83% stake in the combined companies and Allergan shareholders will have a 17% ownership. AbbVie is expected to generate significant annual operating cash flow, which will support a debt reduction target of $15 to $18 billion before the end of 2021.

https://www.biospace.com/article/abbvie-to-acquire-allergan-for-63-billion/