FDA approved Entresto sacubitril/valsartan (LCZ696) from Novartis AG (NYSE:NVS; SIX:NOVN) to reduce the risk of cardiovascular death and hospitalization for heart failure in chronic heart failure patients with reduced ejection fraction.
Novartis spokesperson Julie Masow told BioCentury the company would begin shipping the drug "very soon" at a wholesale acquisition cost (WAC) of $12.50 a day, less discounts.
Masow told BioCentury the company has "reached out to a few U.S. payers to discuss potential pricing models linked to clinical outcomes, including a reduction in heart failure hospitalizations." She said discussions have been "encouraging" but remain in the early stages.
FDA reviewed the crystalline complex of valsartan and sacubitril in an equimolar ratio under Priority Review. The agency based its approval on results of the Phase III PARADIGM-HF study, in which Entresto reduced the rate of cardiovascular death or heart failure hospitalization compared to enalapril, a generic angiotensin-converting enzyme (ACE) inhibitor.
Depomed Inc. (NASDAQ:DEPO) gained $7.98 (39%) to $28.62 after it received an unsolicited bid from Horizon Pharma plc (NASDAQ:HZNP) to acquire the company for $29.25 per share, a 42% premium to Depomed's close of $20.64 on Monday. The all-stock deal would value Depomed at $1.8 billion. Depomed said it rejected a takeover proposal Horizon sent on May 27 and another on June 12 that Depomed said was "identical in all material respects."
The proposed deal would give Horizon a portfolio of CNS therapies, including several analgesics. Gralise, a once-daily formulation of gabapentin using Acuform delivery technology that is approved to treat post-herpetic neuralgia (PHN), accounted for $17.2 million in revenues during 1Q15, or 55% of Depomed's product sales. Depomed obtained U.S. rights earlier this year to the Nucynta tapentadol analgesic franchise, consisting of formulations of a mu opioid receptor (MOR) agonist and norepinephrine reuptake inhibitor, from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Jan. 15).
Horizon said it would retire Depomed's $575 million in senior secured notes with cash and newly issued debt, and that the acquisition would be "immediately and substantially" accretive to the company's adjusted diluted EPS.
Depomed said its shareholders would own 27% of the combined company, but it believes its contributions to the combined company's financial metrics "would be much greater" and that its product portfolio's growth rate "appears to far exceed" Horizon's in 2016 and beyond.
Citigroup and Jefferies are advising Horizon. Morgan Stanley and Leerink Partners are advising Depomed, and Baker Botts is its counsel.
Allergan plc (NYSE:AGN) obtained an exclusive, worldwide license to migraine candidates MK-1602 and MK-8031 from Merck & Co. Inc. (NYSE:MRK) for $250 million up front. Both compounds are oral calcitonin gene-related peptide (CGRP) receptor antagonists.
Allergan expects to begin Phase III testing next year of MK-1602 to treat migraines. Merck completed two Phase II trials of MK-1602 in 2012; Merck spokesperson Lainie Keller said data from these trials have not been published. Allergan intends to begin a Phase II study in 2016 of MK-8031 to prevent migraines.
Allergan will pay Merck $125 million when the deal receives regulatory clearance and $125 million in April 2016. Merck is also eligible for undisclosed milestones and tiered royalties. Allergan will lead development, manufacturing and commercialization of both compounds.
Merck previously discontinued development of two oral CGRP receptor antagonists. It halted development of telcagepant (MK-0974) in 2011 due to elevated liver transaminases in an extension of a Phase II study, and of MK-3207 in 2009 due to "asymptomatic liver test abnormalities" in extended Phase I studies.
The companies said MK-1602 and MK-8301 belong to a "different chemical series" than telcagepant and MK-3207, and noted that neither candidate has shown evidence of liver toxicity in clinical testing.
Alder Biopharmaceuticals Inc. (NASDAQ:ALDR), Amgen Inc. (NASDAQ:AMGN), Eli Lilly and Co. (NYSE:LLY) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) are developing mAbs targeting CGRP for migraine. Alder dipped $3.62 to $48.72 on Tuesday.
Zhejiang Hisun Pharmaceuticals Co. Ltd. (Shanghai:600267) said it signed a non-binding memorandum of understanding with Sanofi (Euronext:SAN; NYSE:SNY) to explore the formation of a joint venture in China to develop, produce and commercialize diabetes therapies, including insulin and insulin analogs.
In 2012, Zhejiang Hisun and Pfizer Inc. (NYSE:PFE) launched Hisun-Pfizer Pharmaceuticals Co. Ltd., a China-based JV to develop and commercialize generics.
The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) launched an expanded access program for daratumumab to treat multiple myeloma in heavily pre-treated U.S. patients. Janssen said the compound will be available at up to 40 U.S. sites, and that the Multiple Myeloma Research Foundation (MMRF) helped identify locations for the program.
Last month, Janssen started submitting a rolling BLA to FDA for the human mAb against CD38. The compound has breakthrough therapy and Fast Track designations from FDA. J&J has exclusive, worldwide rights to daratumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY).
The daratumumab BLA is based primarily on data from a Phase II monotherapy study presented at this year's American Society of Clinical Oncology (ASCO) meeting that showed double-refractory MM patients had an ORR of 29.2%, a median duration of response of 7.4 months, and a one-year survival rate of 65% (see BioCentury, June 8).
FDA granted breakthrough therapy designation to DX-2930 from Dyax Corp. (NASDAQ:DYAX) to prevent prevent hereditary angioedema attacks.
In late March, Dyax rose sharply after the human mAb against plasma kallikrein significantly reduced HAE attacks in a Phase Ib trial and received Fast Track designation from FDA (see BioCentury Extra, April 1). On Tuesday, Dyax gained $0.05 to $26.67.
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) signed a non-binding letter of intent to grant China National Pharmaceutical Group Corp. (Sinopharm) (Beijing, China) and Hefei Life Science & Technology Park Investments and Development Co. Ltd. (Hefei, China) exclusive Chinese rights to ORMD-0801 to treat Type II diabetes.
Under the proposed deal, Oramed would receive $12 million through the sale of 1.2 million shares to Sinopharm and Hefei at $10.39; the investors would receive a 10% stake. The split of shares between Sinopharm and Hefei wasn't disclosed. Oramed would receive $18 million upon the close of the licensing agreement and be eligible for $20 million after it reports results from an ongoing U.S. Phase IIb trial of ORMD-0801, plus a 10% royalty on sales of the oral capsule formulation of insulin. Oramed said last week it expects to complete the Phase IIb trial in 2Q16.
Oramed will receive $500,000 to negotiate exclusively with Sinopharm and Hefei for 60 days.
Oramed gained $0.28 to $7.19 on Tuesday.
The Association of Community Cancer Centers (ACCC) launched the Institute for Clinical Immuno-Oncology (ICLIO), an educational initiative to increase adoption of immuno-oncology therapies. Bristol-Myers Squibb Co. (NYSE:BMY) donated an undisclosed sum to support the initiative.
ACCC spokesperson Lori Gardner told BioCentury ICLIO seeks to provide educational tools to physicians, academics, insurers, social workers and other parties involved in patient access to cancer immunotherapies. ICLIO will provide free newsletters and online courses; it plans to host a conference in October and start a preceptorship program next year.
BMS markets two immuno-oncology therapies: Yervoy ipilimumab, a human mAb against CTLA-4 receptor, to treat advanced melanoma; and Opdivo nivolumab, a human IgG4 mAb against PD-1, to treat melanoma and non-small cell lung cancer (NSCLC).
Ophthalmology company GenSight Biologics S.A. (Paris, France) hired Thomas Gidoin as CFO. He was director of corporate finance at DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT).
Diagnostics company Metabolon Inc. (Durham, N.C.) named Darin Leigh chief commercial officer. Leigh was SVP of commercial operations at Asuragen Inc. (Austin, Texas).
Abingworth named Tim Haines and Kurt von Emster joint managing partners. Haines joined Abingworth in 2005 as a partner in the London office. von Emster joined in January as a partner in the Menlo Park, Calif., office; he had co-founded venBio in 2009 (see BioCentury Extra, Dec. 5, 2014).
Stephen Bunting, who had been Abingworth's managing partner since 2002, became chairman.
Republican budget hawks in the U.S. House have launched an effort to make funding increases for NIH and FDA discretionary under the proposed 21st Century Cures Act (H.R. 6), a change that would render them subject to the annual congressional appropriations process. The current draft of the bill includes two mandatory funds that would provide $8.8 billion to NIH and $550 million to FDA over five years.
Rep. Fred Upton (R-Mich.), chairman of the Energy & Commerce Committee, made the funding mandatory in order to gain Democratic support. Switching to discretionary funding would erode or eliminate support from Democrats. Rep. Dave Brat (R-Va.) and three other Tea Party Republicans -- Rep. Tom McClintock (R-Calif.), Rep. Scott Garrett (R-N.J.), and Rep. Marlin Stutzman (R-Ind.) -- introduced an amendment to H.R. 6 on Tuesday that would make the NIH Innovation Fund discretionary. The Tea Party think tank Heritage Action for America Tuesday issued a statement calling on lawmakers to oppose H.R. 6 because of its creation of a mandatory spending stream.
The Republican leadership is supporting H.R. 6, and Brat's amendment is unlikely to pass. House Speaker John Boehner (R-Ohio) Tuesday tweeted and blogged about his support for H.R. 6, noting that it "provides dedicated resources for NIH and the FDA that are fully paid for and sunset after five years."
A total of 29 amendments to H.R. 6 were filed Tuesday. Rep. Paul Gosar (R-Ariz.), a Tea Party conservative, and the liberal Democrat Rep. Jan Schakowsky (R-Ill.) introduced separate amendments that would delete a section of H.R. 6 that seeks to give manufacturers six months of market exclusivity if they obtain FDA approval to repurpose an approved drug for an Orphan indication. Schakowsky also filed an amendment that would require drug manufacturers to disclose publicly the R&D costs for compounds for which they seek approval, including NIH's contribution to R&D.
The House is expected to vote on the bill this week.
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