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Forest Laboratories Inc. (NYSE:FRX) said longtime President and CEO Howard Solomon will retire at the end of the year. Solomon will remain chairman through Forest's 2014 annual general meeting, after which he will become chairman emeritus. Forest said it is evaluating internal and external candidates and expects to name Solomon's successor by year end. Solomon joined Forest as a director in 1964 and has served as CEO since 1977. Forest was up $2.02 to $39.53 on Thursday.
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Infectious disease company Cardeas Pharma Corp. (Seattle, Wash.) raised $34 million in a series B round led by new investor H.I.G. BioVentures. Existing investors Novo A/S; Avalon Ventures; Devon Park Bioventures; and WRF Capital also participated, along with new investor Delphi Ventures. H.I.G. BioVentures' Aaron Davidson will join Cardeas' board.
Cardeas is developing an aerosolized formulation of antibiotics amikacin and fosfomycin delivered via an eFlow Nebulizer system from Pari GmbH (Starnberg, Germany) to treat healthcare-associated pneumonia in patients on mechanical ventilation. The product has completed a Phase Ib trial in patients with ventilator-associated pneumonia (VAP) or ventilator-associated tracheobronchitis.
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Cancer company Jennerex Biotherapeutics Inc. (San Francisco, Calif.) raised $21.6 million in an undisclosed venture round from undisclosed investors. The biotech's Pexa-Vec (JX-594) is in the Phase IIb TRANSVERSE trial to treat hepatocellular carcinoma (HCC), with Phase III testing slated to start next year. The recombinant vaccinia virus (addition of GM-CSF and deletion of thymidine kinase) is also in Phase II testing to treat colorectal and kidney cancer.
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Apricus Biosciences Inc. (NASDAQ:APRI) raised $17.1 million through the sale of 6 million shares at $2.85 in a follow-on underwritten by Lazard; Roth Capital Partners; and Cantor Fitzgerald. The underwriters also received five-year warrants to purchase up to 3 million shares at $3.40 per share. Apricus proposed the follow-on late Wednesday, when its share price was $3.30. On Thursday, the company was down $0.65 (20%) to $2.65.
Apricus' Vitaros alprostadil, a topical prostaglandin E1 (PGE1) cream formulated with the company's NexACT transdermal delivery technology, is approved in Canada to treat erectile dysfunction (ED). The company is also developing Femprox alprostadil topical cream to treat female sexual arousal disorder (FSAD).
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Japanese gene therapy company AnGes MG Inc. (Tokyo:4563) raised Y1.1 billion ($11.2 million) after Merrill Lynch Japan Securities exercised 4,000 stock acquisition rights at Y287,100. Each right entitles Merrill to purchase a share at 90% of the previous day's closing price, with a minimum exercise price of Y253,600. Merrill now has 16,000 acquisition rights outstanding. The rights are exercisable through May 19, 2014. AnGes was off Y41,000 (13%) to Y270,000 on Thursday.
AnGes has an SPA from FDA for a Phase III trial to evaluate Collategen beperminogene perplasmid to treat critical limb ischemia (CLI) in patients with peripheral arterial disease (PAD). The product is a plasmid encoding human hepatocyte growth factor/scatter factor (HGF/SF) that uses DNA delivery technology from Vical Inc.(NASDAQ:VICL). Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508) has exclusive, U.S. marketing rights to Collategene, and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) has Japanese marketing rights for PAD and CLI.
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PeptiDream Inc. (Tokyo, Japan) amended its IPO and now plans to sell 1.7 million shares at Y1,920-Y2,500 in an IPO on the Tokyo Stock Exchange's market of the high-growth and emerging stocks (Mothers). At the Y2,210 mid-point, PeptiDream would raise Y3.8 billion ($36.6 million) and be valued at Y35.6 billion ($346.2 million). Mizuho is the lead underwriter. PeptiDream said it expects the offer to be priced on or after May 31, with the shares slated to start trading in June. Earlier this month, PeptiDream said it planned to sell the shares at Y1,720-Y1,920. The company's founders plan to sell an additional 1 million shares in the IPO.
PeptiDream's Peptide Discovery Platform System (PDPS) enables incorporation of modified unnatural amino acids into mRNA display peptide libraries. The company said one of the motivations for an IPO was concern over a potential take-out by one of the company's partners; PeptiDream has active target discovery deals with a number of companies, including Novartis AG (NYSE:NVS; SIX:NOVN), Ipsen Group (Euronext:IPN; Pink:IPSEY), the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) (see BioCentury, May 20).
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Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said once-daily 3 mg subcutaneous liraglutide met the three co-primary endpoints in the Phase IIIa SCALE Obesity and Pre-diabetes trial to treat obesity. Liraglutide reduced mean body weight from baseline to week 56 (8% vs. 2.6%). It also increased the proportion of patients who achieved weight loss of 5% or greater (64% vs. 27%) and greater than 10% (33% vs. 10%) of baseline body weight at week 56 vs. placebo. P-values were not disclosed.
According to FDA's 2007 draft guidance, obesity drugs must have either a 5% placebo-adjusted weight loss, or at least 35% of patients in the treatment arm must experience 5% or greater body weight loss and this proportion must be at least double the proportion in the placebo group. Liraglutide met both benchmarks in the double-blind trial, which enrolled 3,731 patients without diabetes who are overweight or obese with co-morbidities such as pre-diabetes, hypertension and dyslipidemia.
The trial is the third of four Phase III studies in the SCALE program evaluating 3 mg liraglutide for weight management in patients who are overweight or obese with or without co-morbidities. Novo Nordisk has already reported data from the first two trials (see BioCentury, April 8).
Novo expects to complete the Phase IIIa SCALE Sleep apnea trial in 3Q13 and submit regulatory applications in the U.S. and EU for the 3 mg dose of liraglutide at year end or early 2014. The company markets once-daily 1.2 and 1.8 mg doses of liraglutide, a long-acting analog of glucagon-like peptide-1 (GLP-1), as Victoza in the U.S. and EU to treat Type II diabetes.
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Merck & Co. Inc. (NYSE:MRK) said it no longer plans to submit regulatory applications for preladenant to treat Parkinson's disease after an initial review of data from three double-blind Phase III trials "did not provide evidence of efficacy" for the selective adenosine A2A receptor (ADORA2A) antagonist compared to placebo. Merck also said it will discontinue the extension phases of the trials. Two of the Phase III trials evaluated preladenant when added to levodopa therapy in patients with moderate to severe PD, and one trial evaluated the compound as monotherapy in patients with early PD. Merck declined to disclose details.
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Astellas Pharma Inc. (Tokyo:4503) said the Netherlands Medicines Evaluation Board approved an MAA for Vesomni solifenacin/tamsulosin (EC905) to treat moderate to severe storage symptoms and voiding symptoms associated with benign prostatic hyperplasia (BPH). The MAA was approved under the EU Mutual Recognition Procedure, with the Netherlands acting as the reference member state. Vesomni is a once-daily, fixed-dose combination of Astellas' overactive bladder drug Vesicare solifenacin and its BPH drug Harnal tamsulosin.
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FDA accepted and granted Priority Review to an sNDA from Celgene Corp. (NASDAQ:CELG) seeking to expand the label of Abraxane nab-paclitaxel to include first-line treatment of advanced pancreatic cancer in combination with gemcitabine. The PDUFA date is Sept. 21. Celgene also said EMA accepted for review in April a Type II variation application to expand the European label for the albumin stabilized nanoparticle formulation of paclitaxel to include the indication. Both applications include data from the Phase III MPACT trial (see BioCentury Extra, Jan. 23).
Abraxane is approved in the U.S. for first-line treatment of advanced non-small cell lung cancer (NSCLC), and in the U.S., EU and at least 12 other countries as second-line treatment of metastatic breast cancer. Celgene was up $0.20 to $123.64 on Thursday.
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Uptake in Korea of Remsima infliximab, a biosimilar version of autoimmune drug Remicade infliximab, has been "relatively slow," according to Kim Taylor, company group chairman, pharmaceuticals, Asia Pacific at Johnson & Johnson (NYSE:JNJ). J&J markets Remicade, while Celltrion Inc. (KOSDAQ:068270) markets the biosimilar Remsima, which was approved in Korea in August 2012. Speaking on Thursday at J&J's annual R&D analyst day, Taylor said "we are not seeing major switches and we are still seeing very strong performance with Remicade in Korea." She cited "physician hesitance over switching patients and physician confidence in our product."
J&J expects biosimilars to compete like lower-cost branded drugs said Joaquin Duato, worldwide chairman, pharmaceuticals at the pharma. Duato said Celltrion sells Remsima in Korea at a 5% discount to Remicade. Celltrion did not respond to a request for comments on Remsima's pricing or market penetration. The company has previously said it expects a decision in June on an MAA for Remsima, which is partnered with Hospira Inc. (NYSE:HSP). J&J's partner Merck & Co. Inc. (NYSE:MRK) markets Remicade in Europe, as well as Turkey and Russia.
J&J recorded $6.1 billion in worldwide sales of Remicade in 2012. The patents covering Remicade will expire in Europe in 2015, and in the U.S. in 2018, according to the pharma. In February, Amgen Inc. (NASDAQ:AMGN) disclosed it is developing a biosimilar version of Remicade in partnership with Actavis Inc. (NYSE:ACT).
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Elan Corp. plc (NYSE:ELN) raised $850 million in a bumped-up notes deal on Thursday, and the biotech's board also unanimously rejected a revised offer from Royalty Pharma (New York, N.Y.) to acquire the company. Elan proposed to raise $800 million in the note deal on Monday, alongside proposed moves for a spinout, a $200 million share buyback and the acquisition of two companies. Royalty subsequently raised its offer to acquire Elan to $12.50 per share from $11.25, valuing Elan at $6.4 billion (see BioCentury Extra, May 20).
On Thursday, Royalty said it lowered to 50% plus a share from 90% the number of Elan shares that must be tendered for Royalty to consider the tender successful. Royalty's bid is contingent on Elan shareholders rejecting Monday's deals, as well as this month's proposed deal to pay Theravance Inc. (NASDAQ:THRX) $1 billion in cash in exchange for a 21% interest in the royalties Theravance is eligible to receive from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for four respiratory programs (see BioCentury, May 20).
Elan, which priced the $850 million in 6.25% senior notes due 2021 after market close, was up $0.32 to $12.36 on Thursday.
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Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) said it is "currently pursuing its available legal remedies" against some former shareholders of Daiichi's majority owned subsidiary Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359). Daiichi said the former shareholders "concealed and misrepresented critical information" concerning investigations by the U.S. Department of Justice and FDA into Ranbaxy. Ranbaxy fell Rs30.05 to Rs401 on NSE on Thursday. The stock fell Rs37.95 to Rs393.15 on BSE. Daiichi Sankyo fell Y137 to Y1,812 on Thursday.
Earlier this month, Ranbaxy pled guilty in the U.S. to felony charges and settled civil claims relating to the manufacture and distribution of generic drugs made in violation of cGMP practices at its Indian manufacturing facilities. Ranbaxy agreed to pay a total of $500 million to settle the charges.
Daiichi, which owns a 64% stake in Ranbaxy, first acquired a 35% stake in the company in 2008 from former Ranbaxy CEO and Managing Director Malvinder Mohan Singh and his family, as well as the companies of the Singh family. In a statement, the Singh family said Daiichi was made aware of the investigations and given full access to related documents before it bought the stake.
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Vivus Inc. (NASDAQ:VVUS) investor First Manhattan Co. added three additional nominees, including Alex Denner, to its slate of proposed directors for the biotech's board. Denner had been a managing director of entities associated with Carl Icahn since 2006, but he departed and last year founded hedge fund Sarissa Capital Management. Sarissa has a 2% stake in Vivus. First Manhattan also added Rolf Bass, former head of EMA's Human Medicines Evaluation Unit, and Melvin Keating, former president and CEO of Alliance Semiconductor Corp., to its slate.
First Manhattan, which has been a Vivus shareholder since 2008 and holds a 9.9% stake, is dissatisfied with Vivus' launch of obesity drug Qsymia phentermine/topiramate, which had 1Q13 revenues of $4.1 million. The firm said its additional nominees are in response to Vivus' addition of three new directors to its board earlier this month (see BioCentury, May 20).
Vivus shareholders will vote on the nominees at the company's July 15 annual general meeting. Vivus was up $0.98 to $14.50 on Thursday.
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BTG plc (LSE:BTG) raised L106.3 million ($161.5 million) through the sale of 32.3 million shares at 330p in a placing on Thursday and also announced a pair of deals. BTG will acquire TheraSphere liver cancer therapy from Nordion Inc. (TSX:NDN; NYSE:NDZ) for $200 million. The product, which had revenues of $48 million for the fiscal year ended Oct. 31, 2012, is marketed in the U.S. under a Humanitarian Device Exemption (HDE) to treat unresectable hepatocellular carcinoma (HCC) and HCC in patients with portal vein thrombosis (PVT). TheraSphere -- yttrium-90 glass microspheres used for localized radioembolization therapy -- is approved in Europe and Canada to treat hepatic neoplasia.
BTG also will acquire medical device company Ekos Corp. (Bothell, Wash.) for $180 million up front, plus up to $40 million in milestones. Ekos, which had 2012 product sales of $28 million, markets its EkoSonic endovascular system in the U.S. and EU to treat severe blood clots. EkoSonic delivers thrombolytic drugs and ultrasound through a catheter to break clots. Both deals are subject to shareholder approval.
BTG was up 1.10p to 339.50p on Thursday. Nordion was up C$0.85 to C$8.16 on the day. On the NYSE, the stock was up $0.90 (13%) to $8.02
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The California Institute for Regenerative Medicine awarded a total of $42.4 million on Tuesday to Sangamo BioSciences Inc. (NASDAQ:SGMO) and six stem cell scientists. Sangamo received $6.4 million under the second round of CIRM's Strategic Partnership Awards Initiative, and will use the funds to develop an undisclosed therapeutic for beta-thalassemia. Under the initiative, companies are expected to finish a Phase I trial in four years (see BioCentury Extra, April 17, 2012).
The scientists, who will receive $36 million under CIRM's Research Leadership Awards, will take positions at California universities and research institutions to pursue projects in stem cell research and regenerative medicine.
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