FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8-5 to recommend approval of Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) to treat hypoparathyroidism. The PDUFA date is October 24.
There are currently no drugs approved for hypoparathyroidism. The standard of care is calcium and vitamin D. In briefing documents released ahead of Friday's EMDAC meeting, FDA reviewers concluded that once-daily subcutaneous injections of Natpara reduced the need for calcium and vitamin D supplements in patients with the condition (see BioCentury Extra, Sept. 10).
NPS CEO Francois Nader said in a conference call after the meeting that the company hopes to launch the recombinant human parathyroid hormone 1-84 (PTH) in January 2015.
Earlier this week, Nader told BioCentury that NPS is not planning to partner Natpara. He said the company has the infrastructure in place to commercialize the compound in several countries. NPS plans to submit an MAA to EMA to treat hypoparathyroidism by year end.
In briefing documents released Wednesday, reviewers noted that rates of osteosarcoma in Natpara-treated rats were similar to those seen with Forteo teriparatide, a PTH fragment from Eli Lilly and Co. (NYSE:LLY) that is approved for osteoporosis. Forteo's label contains a boxed warning for the potential risk of osteosarcoma and is not indicated for use beyond two years.
Trading of NPS was halted on Friday. Shares lost $1.77 to $30.93 in subsequent after-hours trading.
Affimed Therapeutics B.V. (NASDAQ:AFMD) was down $1.30 to $5.70 on its first day of trading Friday after raising $56 million through the sale of 8 million shares at $7 in an IPO. The IPO price values the company at $167.9 million. Earlier this month, the company said it planned to sell 6.3 million shares at $11-$13. A midpoint sale of those shares would have raised $75.6 million. Jefferies; Leerink Partners; BMO Capital Markets Corp.; and Trout Capital are underwriters.
Affimed raised EUR 11.7 million ($15.4 million) from existing investors in a series E round last week. Investors included Aeris Capital; BioMedInvest; LSP-Life Sciences Partners; Novo Nordisk A/S (CSE:NVO; NYSE:NVO); and OrbiMed. Affimed also received a EUR 10.5 million ($13.8 million) loan from Perceptive Advisors (see BioCentury, Sept. 2).
Next quarter, Affimed plans to start Phase IIb testing of lead candidate AFM13 to treat Hodgkin's lymphoma in patients who have relapsed or are refractory to Adcetris brentuximab from Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). AFM13 is a tetravalent bispecific human antibody targeting CD30 and CD16.
The IPO is the first for a German biotech since 2010, when Formycon AG listed on the Frankfurt Stock Exchange.
AM-Pharma B.V. (Bunnik, The Netherlands) raised EUR 12.2 million ($15.8 million) in a tranched series E round led by Gilde Healthcare.
Existing investors participating in the new round included the venture arm of AbbVie (NYSE:ABBV); BB Biotech Ventures; Idinvest Partners; Inventages Venture Capital; Kurma Biofund; and Ysios Capital Partners. The round includes two tranches, but AM-Pharma declined to disclose details of its structure.
AM-Pharma plans to complete a Phase II trial of recAP recombinant alkaline phosphatase to treat acute kidney injury (AKI). It also is preparing for Phase II testing of an oral version of recAP to treat ulcerative colitis (UC).
Polar Capital is fundraising for an open-ended global biotech fund focused on large cap companies. The Polar Capital Healthcare Blue Chip Fund will be managed by Gareth Powell and Daniel Mahony, who have both been with Polar since 2007.
The new fund, to be listed on the Irish Stock Exchange, is targeting a portfolio of 25-30 pharmaceutical, biotechnology, medical device and healthcare service companies.
Last year Polar started fundraising for its Biotechnology Fund, focused across all therapeutic areas, stages of development and market caps (see BioCentury, Nov. 18, 2013).
Kolltan Pharmaceuticals Inc. (New Haven, Conn.) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by Leerink Partners; Stifel; Guggenheim Securities; and Janney Montgomery Scott.
Kolltan's KTN3379 is in Phase I testing to treat solid tumors. Next half, Kolltan expects to announce Phase I results and start Phase II testing of the human mAb against epidermal growth factor receptor 3 (EGFR3; HER3; ErbB3) in solid tumors.
Kolltan acquired Xetrios Therapeutics Inc. last month for 2.4 million shares and $360,000 in cash. In the acquisition, Kolltan obtained exclusive IP rights to therapeutics targeting the TAM receptor tyrosine kinases, the family that includes TYRO3 protein tyrosine kinase (TYRO3; SKY), AXL receptor tyrosine kinase (AXL; UFO) and c-Mer proto-oncogene tyrosine kinase (MERTK).
Eli Lilly and Co. (NYSE:LLY) said ramucirumab plus chemotherapy increased overall survival, the primary endpoint, in a Phase III trial as second-line therapy for metastatic colorectal cancer (mCRC). The company declined to provide specific data until it presents them at an unspecified scientific meeting in 2015.
The human IgG1 mAb VEGFR-2 antagonist also increased progression-free survival, a secondary endpoint.
Ramucirumab is approved as Cyramza in the U.S. as a second-line monotherapy to treat advanced stomach cancer or gastroesophageal junction adenocarcinoma, an indication for which the drug is under review in Europe. A European decision is expect in 1Q15.
Lilly said it plans to "initiate regulatory submissions" in mCRC in 1H15 but would not disclose where it would submit them. It plans to submit an sBLA to FDA for ramucirumab to treat non-small cell lung cancer (NSCLC) by year end.
Oncothyreon Inc. (NASDAQ:ONTY) said in an SEC filing that partner Merck KGaA (Xetra:MRK) will stop development of tecemotide (L-BLP25) as a monotherapy for non-small cell lung cancer (NSCLC). The compound was in Phase III testing.
Last month, tecemotide missed the primary endpoint in a Japanese Phase I/II trial in the indication. Shares of the biotech fell $0.48 (17%) to $2.30 that day (see BioCentury Extra, Aug. 19).
Merck has exclusive, worldwide rights from Oncothyreon to tecemotide, a liposomal vaccine containing a synthetic 25 amino acid peptide sequence from mucin 1 (MUC1; CD227).
Oncothyreon was off $0.02 to $2.23 on Friday. Its only other unpartnered clinical candidate is ONT-10, a liposomal glycolipopeptide cancer vaccine targeting mucin 1 (MUC1; CD227) in Phase Ib.
Delenex Therapeutics AG (Zurich, Switzerland) said DLX105 led to no significant clinical improvements in a Phase II trial in mild to moderate plaque psoriasis. The co-primary efficacy endpoints were local Psoriasis Area Severity Index (PASI) score per plaque vs. baseline and placebo.
The company said DLX105 significantly decreased mRNA levels of pro-inflammatory molecules vs. placebo at day 14. Delenex also said it expects to see clinical activity and an impact on PASI score with longer treatment periods with increased drug concentrations in the skin. The company said it is finalizing decisions about next steps, including treatment regimens, for the topical formulation of an anti-TNF alpha mAb fragment.
The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing Sept. 19 to discuss ways to combat antibiotic resistance and foster new drug development. The event is part of the committee's 21st Century Cures initiative.
Kathy Hudson, deputy director for science, outreach and policy at NIH; Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) described 21st Century Cures' goals on the June 1 edition of BioCentury This Week television (see BioCentury This Week, June 1).
EMA released a guide addressing frequently asked questions about its adaptive licensing program.
The program is designed to potentially allow companies to market new products for limited populations based on promising but early data.
The agency launched the project in March and selected the first two products to be included in a pilot project in June (see BioCentury Extra, June 6).
In a Phase III dry eye trial, MIM-D3 from Mimetogen Pharmaceuticals Inc. (Montreal, Quebec) significantly improved total corneal fluorescein staining vs. placebo (p=0.05). The Sept. 10 BioCentury Extra misstated the result.
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