Dezima Pharma B.V. (Naarden, the Netherlands) said TA-8995 (DEZ-001) alone or in combination with statin therapy met the primary endpoint vs. placebo in the 364-patient Phase IIb TULIP trial to treat dyslipidemia. The primary endpoint was a composite of the change from baseline in LDL-C and HDL-C at week 12.
Dezima plans to publish full data in the coming months and start a Phase III trial next year. The company has exclusive, worldwide rights, excluding certain Asian territories, to the cholesteryl ester transfer protein (CETP) inhibitor from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) (see BioCentury, Jan. 28, 2013).
Two other CETP inhibitors are already in Phase III trials: anacetrapib (MK-0859) from Merck & Co. Inc. (NYSE:MRK) and evacetrapib (LY2484595) from Eli Lilly and Co. (NYSE:LLY).
In a primate study, ZMapp from Mapp Biopharmaceutical Inc. (San Diego, Calif.) reversed 100% of advanced Ebola cases. A research group led by Gary Kobinger of the University of Manitoba that included Mapp CEO Larry Zeitlin published a paper in Nature showing all 18 rhesus monkeys survived when treated with ZMapp up to five days post infection, with severe symptoms reversed.
ZMapp combines components of mAbs targeting Ebola glycoproteins GP1 and GP2 from Mapp's MB-003 and ZMab from Defyrus Inc. (Toronto, Ontario). Preclinical work describing the effect of MB-003 on Ebola infection in nonhuman primates was published in Science Translational Medicine in 2013 and work describing the effect of ZMab was published in the journal in 2012 (see SciBX: Science Business eXchange, July 26, 2012).
On Aug. 12, Mapp said it had exhausted its supply of ZMapp just days after it said it would increase production "as quickly as possible" (see BioCentury Extra, Aug. 12).
United Therapeutics Corp. (NASDAQ:UTHR) gained $26.14 (29%) to $117.83 on Friday after the U.S. District Court for the District of New Jersey ruled that Sandoz's ANDA for generic intravenous treprostinil will infringe United Therapeutics' U.S. Patent No. 6,765,117.
The '117 patent expires on October 24, 2017. It covers multiple forms of treprostinil, a synthetic long-acting stable prostacyclin analog available from United Therapeutics as Remodulin in both subcutaneous injection and intravenous forms. United Therapeutics also sells an inhalable version as Tyvaso and an oral form as Orenitram.
Sandoz, a unit of Novartis AG (NYSE:NVS; SIX:NOVN), submitted its ANDA in December 2011 and United Therapeutics filed suit in March 2012. United Therapeutics' sales of all forms of treprostinil were $509.2 million in 1H14. Friday's move pushes United Therapeutics' market cap to $5.6 billion.
Titan Pharmaceuticals Inc. (OTCBB:TTNP) proposed to raise up to $12 million through the sale of units in a follow-on underwritten by Roth Capital Partners. Each unit comprises a share and a warrant to purchase a share.
Titan's Probuphine buprenorphine is in a Phase III trial to treat opioid dependence that is designed to address questions from FDA in a 2013 complete response letter for Probuphine. The company and U.S. commercialization partner Braeburn Pharmaceuticals S.p.r.l. (Princeton, N.J.) plan to resubmit an NDA to FDA for the mu opioid receptor agonist by the end of 2015.
Titan was down a penny to $0.65 on Friday.
Orexo AB (SSE:ORX; OTCQX:ORXOY) raised SEK346.5 million ($50.6 million) through the sale of 2.5 million shares at SEK139 in a private placement. The company sold 1.1 million treasury shares and issued 1.4 million new shares. Danske Bank is the sole lead manager and bookrunner. Orexo's Zubsolv buprenorphine/naloxone, a sublingual tablet formulation of buprenorphine and naloxone, is marketed in the U.S. to treat opioid dependence.
Orexo was off SEK4.25 to SEK139 on Friday.
In a memorandum, the White House said all federally funded labs working with infectious agents must take "immediate and longer-term steps" to enhance biosafety and biosecurity, including taking an inventory of infectious samples and reviewing safety and security protocols. The memo was sent to federal agencies earlier this month but made publicly available on Thursday.
The request follows "three recent U.S. biosafety and biosecurity incidents," including the potential, unintentional exposure of laboratory personnel at a U.S. Centers for Disease Control and Prevention lab to viable anthrax.
BioCentury This Week television will broadcast a show about federal biosafety policy on Sept. 2. The program will be broadcast on select PBS stations and will be available at www.BioCenturytv.com.
BioCentury Extra will not publish on Monday, Sept. 1, in observance of the Labor Day holiday in the U.S. Postings of BioCentury Extra will resume on Tuesday, Sept. 2.
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