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Friday, March 1, 2019

GSK gets CHMP nod for IV treatment of complicated flu

GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for intravenous zanamivir for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when the patient’s influenza virus is known or suspected to be resistant to anti-influenza agents other than zanamivir, and/or other anti-viral agents for treatment of influenza, including inhaled zanamivir (Relenza), are not suitable for the individual patient.
The marketing authorisation application was submitted under the exceptional circumstances regulatory legislation in the European Union. A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. When approved, the intravenous formulation of zanamivir will be known as Dectova.
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Tilray Acquires World’s Largest Hemp Foods Firm

Nanaimo, Canada-based Tilray (NASDAQ: TLRY) has acquired Manitoba Harvestfrom Compass Diversified Holdings (NYSE: CODI).
The C$419 million purchase price consists of cash and Class 2 common stock shares of Tilray.
World’s Largest Hemp Food Manufacturer
Headquartered in Winnipeg, Manitoba, Manitoba Harvest is deemed to be the largest hemp food manufacturer in the world.
The company produces and distributes hemp-based consumer products. Its products include Hemp Hearts, Hemp Oil, Hemp Yeah! granola, Hemp Yeah! protein powder and Hemp Bliss milk.
Manitoba’s product are currently sold by about 16,000 retail locations across the U.S.and Canada.
Transaction Details
Of the C$419 million purchase price, Tilray paid C$277.5 million at closing, comprised of C$150 million in cash and C$127.5 million in its shares.
Six months after closing, Tilray will pay C$92.5 million, comprised of C$50 million in cash and C$42.5 million in the company’s stock.
Tilray will issue an additional C$49 million in shares based on Manitoba achieving certain performance milestones in 2019.
Tilray’s Manitoba Harvest Plans
Manitoba will operate as a wholly-owned subsidiary of Tilray.
By working with Manitoba, Tilray plans to develop new CBD wellness products and hemp-based consumer food products. The company plans to use Manitoba’s established distribution network to speed up its expansion into the U.S. and Canadian markets.
Manitoba’s experienced team and manufacturing capabilities – including two BRC AA+ certified manufacturing facilities – will help Tilray grow its product lineup and revenues, according to a Tilray statement.
“We look forward to working collaboratively to develop and distribute a diverse portfolio of branded hemp-derived CBD food and wellness products in the U.S. and Canada,” Tilray President and CEO Brendan Kennedy said in prepared remarks.
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Sanofi: CHMP backs ZynquistaTM (sotagliflozin) for type 1 diabetes

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of ZynquistaTM* (sotagliflozin), developed by Sanofi and Lexicon.
The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3
The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months.
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Portola in $125M Loan Pact with HealthCare Royalty, Athyrium Capital

Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that it has entered into a $125 million loan agreement with HealthCare Royalty Partners (HCR) and investment funds manager Athyrium Capital Management, LP.
“We are pleased to once again be partnering with HCR and to welcome Athyrium as a new strategic partner on this financing agreement, which will support the ongoing commercialization of Andexxa in the U.S. and general business purposes, including launch preparations for Ondexxya™ in Europe,” said Mardi Dier, Portola’s Chief Financial Officer and Chief Business Officer.
The non-dilutive financing agreement provides Portola with up to $125 million of borrowing capacity available in two tranches, each bearing interest at 9.75 percent per annum. Under the terms of the agreement, an initial tranche of $62.5 million will be funded shortly after closing and an additional $62.5 million will be available at Portola’s option, subject to certain conditions. The loan can be prepaid at Portola’s discretion, subject to prepayment fees.
“Today’s announcement is a continuation of our long-standing relationship with Portola and we are proud to support the Company’s ongoing efforts to bring innovative new therapies to patients,” said Clarke B. Futch, Managing Partner at HealthCare Royalty Partners. “There is a clear, unmet need for an antidote that can address life-threatening bleeding associated with the use of Factor Xa inhibitors and we have great confidence in Portola’s ability to deliver on the promise of this potentially life-saving new medicine.”
“We are proud to join HCR in partnering with Portola during such a transformative time in the Company’s history,” said Laurent D. Hermouet, Partner at Athyrium Capital Management. “We believe Portola has the potential to significantly impact the lives of thousands of patients and we are happy to provide additional financial flexibility for the Company during this exciting period of commercial launch.”
Further information with respect to the credit facility will be set forth in the Form 10-K to be filed by Portola with the Securities and Exchange Commission on March 1, 2019.
Cowen acted as Sole Lead Arranger and Financial Advisor to Portola on the transaction.
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Intellia CEO not involved in Starboard’s Bristol-Myers board challenge

Intellia Therapeutics Inc Chief Executive John Leonard, who U.S. drug maker Bristol-Myers Squibb Co said last week was nominated by hedge fund Starboard Value LP to sit on its board, is not affiliated with the effort, an Intellia spokeswoman said on Thursday.

“He is not involved. He has a very demanding job as our CEO and he is on other boards as well,” Jennifer Mound Smoter, Intellia senior vice president for external affairs and communications, said in an interview after Reuters contacted Leonard.
Smoter declined to offer an explanation on how Leonard’s name was included in Starboard’s slate of five directors to challenge Bristol-Myers’ board. Starboard declined to comment.
Leonard is a seasoned pharmaceutical industry executive, having previously held senior positions at Abbott Laboratories and Abbvie Inc.
Starboard’s four other board nominees are Starboard Chief Executive Jeffrey Smith, Shulman Family Ventures managing partner Steven Shulman, Tyree & D’Angelo Partners co-CEO Michael Tyree, and Water Street Healthcare Partner Janet Vergis, according to a regulatory filing by Bristol-Myers.
Starboard’s immediate goal is to muster enough Bristol-Myers shareholder support to shoot down the company’s $74 billion deal to acquire biotech Celgene Corp, the New York-based fund said on Thursday. If it succeeds, it will use the slate to challenge Bristol-Myers’ board, Starboard added.
Starboard reported on Thursday it owned 4.4 million shares, or 0.3 percent, of Bristol’s shares.
A top Bristol-Myers shareholder, Wellington Management, came out against the Celgene deal on Wednesday, criticizing it as too risky and expensive.
Bristol-Myers on Thursday defended the Celgene deal, through which it hopes to create a market leader in the lucrative treatment of cancer by combining two of the world’s biggest-selling portfolios of drugs that treat the disease, as well as adding assets in immunology and inflammation.
Starboard has a track record of opposing deals. It tried to block Virginia-based meat giant Smithfield Foods’ sale to Chinese company Shuanghui International in 2013, as well as aircraft component maker Rockwell Collins Inc’s acquisition of B/E Aerospace two years ago. Both deals were done.
Starboard has been seeking to burnish its credentials in the pharmaceutical sector. Perrigo Company Plc shares have lost more than a third of their value since the drug maker gave Starboard board representation in 2017.
Assertio Therapeutics Inc, previously known as Depomed, explored a sale three years ago under pressure from Starboard but did not reach any deal. Its shares have lost half their value since then.
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Versum Materials Board Rejects Merck KGaA’s Bid

Versum on Friday said its board rejected Merck KGaA unsolicited $48-a-share takeover proposal and said it plans to stick with its all-stock merger with Entegris.
Versum said its board consulted with its independent financial and legal advisers and concluded that the Merck bid isn’t a superior proposal.
Germany’s Merck on Wednesday proposed to buy Versum for about $5.26 billion in cash, offering a 16% premium to Tuesday’s closing price and a nearly 52% premium to Versum’s price before the Entegris deal was announced.
Versum in January agreed to combine with Entegris in a deal that would unite two chemical companies that make critical components for the semiconductor industry. Versum on Friday said the Entegris deal, which would result in Versum shareholders owning 47.5% of the combined company, will create significant long-term value and is in the best interest of its investors.
Versum would be required to pay a $140 million breakup fee to Entegris if it backs out of the deal.
Versum shares, which surged above Merck’s $48 offer price on Wednesday, were still changing hands at $48.71 on Friday morning after Versum announced its rejection of the bid, an indication that investors believe they haven’t heard the final word.
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ImmunoGen Hit as Phase 3 Ovarian Cancer Treatment Fails Endpoint

Shares of Waltham, Mass.-based ImmunoGen, Inc. have plunged nearly 50 percent in premarket trading after the company’s Phase III ovarian cancer treatment failed to meet the primary endpoint of progression-free survival.
ImmunoGen’s FORWARD I trial was testing the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer. The company said that the late-stage study did not hit its primary endpoint in either the entire study population or in the pre-specified subset of patients with high FRα expression.
The 366-patient trial randomized participants 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Data shared from the trial showed that in the entire study population, the confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy, 22 percent vs. 12 percent. ImmunoGen said that was without a significant difference in the primary endpoint of PFS or overall survival.
The majority of the patients in the trial were in the pre-specified high FRα subgroup. In that group, the data shows PFS was longer in patients who received mirvetuximab soravtansine compared with chemotherapy. Also, the confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy, 24 percent compared to 10 percent. Overall survival was longer in patients who received mirvetuximab soravtansine compared with chemotherapy, the company added.

Anna Berkenblit, chief medical officer of ImmunoGen, said based on the efficacy signals observed in the high FRα subset with PFS, confirmed overall response rate and overall survival, the company will conduct additional analyses to further evaluate the potential benefit of mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer. ImmunoGen intends to present additional results from FORWARD I at an upcoming medical meeting.
Kathleen Moore, associate director of clinical research at the Stephenson Cancer Center at the University of Oklahoma and a trial investigator, said that despite the failure to hit the primary endpoint of PFS, she continues to be impressed with the efficacy and tolerability of mirvetuximab soravtansine in ovarian cancer patients.
“I look forward to continuing to work with ImmunoGen to analyze the Phase III data and determine the most appropriate path to bringing mirvetuximab soravtansine to those patients who benefit most from it,” Moore said in a statement.
Mark Enyedy, ImmunoGen’s president and chief executive officer, also expressed his sorrow that the therapy failed to hit its primary endpoint. Enyedy said the company will continue to study the data from the FORWARD I trial to determine the next steps for mirvetuximab as a monotherapy.
“In parallel, we have generated encouraging data with mirvetuximab combination regimens and will evaluate our ongoing studies as an independent path forward to support a registration in ovarian cancer,” Enyedy said in a statement.
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