venBio closed its Global Strategic Fund II with $315 million, above its initial target of $250 million. Strategic LPs Amgen Inc. (NASDAQ:AMGN), Merck & Co. Inc. (NYSE:MRK) and Baxalta Inc. (NYSE:BXLT) contributed most of the fund's money. Baxalta, then part of Baxter International Inc. (NYSE:BAX), and Amgen were LPs in venBio's Fund I.
venBio has made four investments from the new fund and plans to make 10-14 total, the firm's Corey Goodman told BioCentury. The firm also hired Aaron Royston as a principal and Jaume Pons as a venture partner. Royston was a senior associate at Vivo Capital and Pons is president and CEO of Alexo Therapeutics Inc. (San Francisco, Calif.), a venBio portfolio company focused on immuno-oncology.
Wave Life Sciences Ltd. (NASDAQ:WVE) and Pfizer Inc. (NYSE:PFE) partnered to design and develop stereopure nucleic acid therapeutics for metabolic diseases. The partners will investigate therapies for five genetically defined hepatic targets selected by the pharma.
Wave will design and develop the nucleic acids from discovery through clinical candidate selection. The biotech will use Pfizer's hepatic targeting technology and its own technology, which can control precisely the arrangement of Sp or Rp nucleotides within a given nucleic acid and then produce millions of exact copies of the oligonucleotide (see BioCentury, Feb. 15).
In February, President and CEO Paul Bolno told BioCentury that Wave planned to focus its internal efforts on CNS and neuromuscular diseases, and was exploring options including potential strategic partnerships outside of its core focus areas. The deal with Pfizer is Wave's first with an external partner.
Pfizer may opt to license candidates once they are selected. Pfizer has chosen two targets, one of which is apolipoprotein C-III (APOCIII; APOC3). The second is undisclosed. Pfizer is to select the remaining targets within 18 months.
Wave will receive $40 million up front, including $30 million in an equity investment through Pfizer's purchase of 1.9 million shares at $16 per share. The price is a 9% premium to the biotech's close of $14.63 on Wednesday, before the deal was unveiled. The biotech also is eligible for $871 million in milestones across the five programs, plus tiered royalties up to low double-digits on any resulting products.
Pfizer also granted Wave a non-exclusive license to use its hepatic targeting technology for its own hepatic programs outside of the companies' collaboration. Pfizer would be eligible for milestones and tiered royalties for Wave products that use the technology.
Wave rose $0.65 to $15.28 on Thursday.
Clovis Oncology Inc. (NASDAQ:CLVS) said late Thursday that it expects FDA to issue a complete response letter for an NDA for rociletinib (CO-1686). The company intends to focus resources instead on its next most-advanced candidate, rucaparib (CO-338).
Last month, FDA's Oncologic Drugs Advisory Committee voted 12-1 against accelerated approval of rociletinib to treat EGFR-positive non-small cell lung cancer (NSCLC) in patients whose tumors harbor the T790M mutation. ODAC had recommended that FDA wait to decide whether to approve rociletinib until data from the confirmatory Phase III TIGER-3 trial were available. Panel members had encouraged Clovis to whittle the dose arms in the study to just one, and to stratify the trial population based on acetylation status (see BioCentury, April 25).
On Thursday, Clovis instead said it had stopped enrollment in all studies of rociletinib, including TIGER-3, and said it withdrew an MAA for the compound. The company said it will cut 35% of its staff by YE16 compared to YE15, and eliminate or delay hiring for planned new positions.
Clovis expects to have about $220-$235 million in cash at YE16, which it said would fund operations into 2018.
This quarter, Clovis plans to complete submission of a rolling NDA to FDA for rucaparib as monotherapy in patients with germline or somatic BRCA-mutated advanced ovarian cancer who have received multiple prior therapies. The oral inhibitor of poly(ADP-ribose) polymerase-1 (PARP-1) and PARP-2 has breakthrough therapy designation from FDA (see BioCentury Extra, April 6, 2015).
Clovis said it hopes to launch rucaparib in the U.S. by 1Q17, and expects to complete an MAA submission in 4Q16.
By YE16, the biotech intends to firm up development plans for lucitanib (AL3810, E-3810). The small molecule inhibitor of fibroblast growth factor (FGF) receptors (FGFR), platelet derived growth factor receptors (PDGFR) and VEGF receptors is in a Phase II study for treatment-refractory breast cancer.
Clovis reported the news after market hours Thursday, and rose $0.24 to $12.90 in early after-hours trading. It had dipped $0.53 to $12.66 during the regular trading session.
Medivation Inc. (NASDAQ:MDVN) again rejected an acquisition offer from Sanofi (Euronext:SAN; NYSE:SNY) as CEO David Hung insisted Thursday that the company's existing business plan would create more shareholder value than Sanofi's offer. Medivation first rejected Sanofi's $9.3 billion acquisition offer on April 29, saying the offer "substantially undervalues" the company (see BioCentury Extra, April 29).
In a letter to Medivation's board released by Sanofi earlier Thursday, CEO Olivier Brandicourt said Sanofi would appeal directly to Medivation shareholders to remove or replace board members if Medivation did not engage in deal talks.
Brandicourt wrote that Sanofi believed there was "overwhelming support" for a deal from Medivation shareholders, and that Medivation would be trading below $40 if not for Sanofi's $52.50 per share cash offer. Medivation gained $0.16 to $59.22 on Thursday, and added $0.53 to $59.75 in early after-hours trading.
Brandicourt also noted that the offer price was nearly double Medivation's share price at its February low. Medivation dipped to an intraday bottom of $26.41 on Feb. 9.
Even with recent gains, Medivation shares remain below their all-time intraday high of $70.79 in March 2015.
On a conference call after market close, Hung said projected revenue from Xtandi enzalutamide, talazoparib (MDV3800) and pidilizumab (MDV9300) would deliver greater shareholder value than Sanofi's offer. Global sales of prostate cancer treatment Xtandi were $547 million in 1Q16, up 53% from 1Q15.
Medivation and Astellas Pharma Inc. (Tokyo:4503) share rights to Xtandi.
FDA's Anesthetic and Analgesic Drug Products and Risk Management Advisory Committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen (KP201/APAP) from KemPharm Inc. (NASDAQ:KMPH) for the short-term management of acute pain, but 18-2 that the treatment should not be labeled as an abuse-deterrent product.
Committee members said KemPharm did not sufficiently demonstrate Apadaz's abuse deterrent properties, saying that deterrence studies were conducted under best-case scenarios and the company did not adequately address the potential for users to extract the candidate's active ingredient using solvents. According to KemPharm, Apadaz is converted into an active form in the gastrointestinal tract, reducing the risk of its abuse through nasal or intravenous administration.
Apadaz is a formulation of benzhydrocodone, a hydrocodone prodrug, and acetaminophen. The PDUFA date for the application is June 9.
KemPharm trading was halted on Thursday.
Merck & Co. Inc. (NYSE:MRK) President and CEO Kenneth Frazier said the pharma is actively searching for licensing or bolt-on deals, and would consider a deal larger than its $8.4 billion takeout of Cubist Pharmaceuticals Inc. The comments came during the pharma's 1Q16 earnings call on Thursday.
"We're very actively engaged with companies that we think have good science," said Frazier. "You haven't seen the deals come through quite yet, but that doesn't mean that we're not very, very much engaged in active discussions with those companies." He added that many biotech boards and management teams are in the process of adjusting to the "new reality" of lower stock prices and lower valuations.
"I'm not focused on a large consolidation-type merger such as we've seen in the industry in the past," Frazier said. "But I also think that bolt-on acquisitions can be larger than, for example, a Cubist." Merck's deal for the infectious disease company was completed in January 2015.
He said the pharma is looking at deals across the spectrum of development stages, and named immuno-oncology as one area of interest. "We want to be aggressive in going after deals, but we want to do deals that create value for our shareholders," said Frazier.
For the quarter, Merck said sales of PD-1 inhibitor Keytruda pembrolizumab were $249 million, up from $83 million in 1Q15. Sales of HCV therapy Zepatier grazoprevir/elbasvir were $50 million; Merck launched the drug in the U.S. during the quarter.
Merck raised its 2016 non-GAAP EPS guidance to $3.65-$3.77 from $3.60-$3.75.
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gained $17.09 to $377.73 on Thursday after it reported earnings and raised 2016 guidance for sales of its ophthalmic drug Eylea aflibercept. The company now expects 20-25% growth in Eylea's U.S. sales compared to 2015; it had previously guided to 20% growth. U.S. sales of the drug were $781 million in 1Q16, up 44% from $541 million in 1Q15.
Sales of cholesterol-lowering PCSK9 inhibitor Praluent alirocumab were $13 million, up sequentially from $7 million in 4Q15. Regeneron and partner Sanofi (Euronext:SAN; NYSE:SNY) launched Praluent in the U.S. in 3Q15 and in the EU in 4Q15.
Regeneron reported non-GAAP diluted EPS of $2.57, off 11% from 1Q15 and a penny shy of analysts' consensus. Total revenues rose 38% to $1.2 billion, topping the consensus estimate of $1.18 billion. GAAP R&D expenses rose 37% to $470 million in 1Q16.
Regeneron also lowered its guidance for 2016 capital expenditures to $550-$625 million from $580-$680 million.
The U.K.'s NICE issued final appraisal determinations (FADs) recommending the use of PCSK9 inhibitors Praluent alirocumab and Repatha evolocumab. The committee backed both drugs for primary non-familial hypercholesterolemia or mixed dyslipidemia in patients with cardiovascular disease (CVD), and primary heterozygous familial hypercholesterolemia (HeFH) in patients with or without CVD.
Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) market Praluent, while Amgen Inc. (NASDAQ:AMGN) markets Repatha. The European Commission approved both drugs last year.
Both recommendations are contingent on the companies providing the drugs at undisclosed discounts under patient access schemes.
The committee had rebuffed Praluent in February draft guidance, citing a lack of cardiovascular outcomes data and a cost-effectiveness estimate outside the range normally considered acceptable (see BioCentury Extra, Feb. 8).
The Repatha recommendation is largely in line with February draft guidance, in which NICE recommended a specific dose of the cholesterol drug. The committee initially declined to recommend Repatha in November 2015.
Amgen rose $0.07 to $154.25 on Thursday. Regeneron, which gained $17.09 to $377.73, also reported earnings (see above).
Gene editing company Intellia Therapeutics Inc. (NASDAQ:NTLA) raised $108 million on Thursday through the sale of 6 million shares at $18 in an IPO underwritten by Credit Suisse, Jefferies, Leerink and Wedbush PacGrow. In a regulatory filing earlier Thursday, Intellia said it hoped to sell 5 million shares at $16-$18.
Intellia is one of a handful of companies developing products using CRISPR-Cas9 (CRISPR-associated protein 9) genome editing technology. The first to go public, Editas Medicine Inc. (NASDAQ:EDIT), closed at $31.99 on Thursday, up 100% from its Feb. 2 IPO price of $16.
Intellia expects its shares to begin trading on Friday.
ViewPoint Therapeutics Inc. (San Francisco, Calif.) raised $4 million in a series A round co-led by Mission Bay Capital and Lagunita BioSciences. Biotechnology Value Fund, the University of Michigan MINTS initiative, Asset Management Ventures and individual investors also participated.
Housed in the San Francisco JLABS hub of Johnson & Johnson (NYSE:JNJ), ViewPoint is developing therapeutics that target misfolded proteins to prevent or treat cataracts. CSO Leah Makley declined to say when preclinical lead program VP1-001, a small molecule stabilizer of alpha-crystallin, would enter the clinic (see BioCentury Innovations, Nov. 12, 2015).
Mission Bay's Douglas Crawford and Lagunita's Mark Blumenkranz joined ViewPoint's board.
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) raised $89.8 million through the sale of 29.9 million shares to institutional investors at $3 in a registered direct offering.
FDA is reviewing Synergy's plecanatide (SP-304), a uroguanylin analog and guanylate cyclase C (GCC; GUCY2C) agonist, to treat chronic idiopathic constipation. Its PDUFA date is Jan. 29, 2017 (see BioCentury Extra, April 19).
Synergy slipped $0.07 to $2.83 on Thursday.
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