Biosimilar company Epirus Biopharmaceuticals Inc. (Boston, Mass.) raised $36 million in a series B round and said it will reverse-merge with Zalicus Inc. (NASDAQ:ZLCS) in an all-stock deal. The combined, publicly traded company will retain Epirus' name and focus on biosimilars. Epirus President and CEO Amit Munshi will be president and CEO, and Zalicus President and CEO Mark Corrigan will be chairman. Epirus shareholders will own 81-86% of the combined company and Zalicus shareholders the balance, depending on Zalicus' net cash when the deal closes. At Dec. 31, 2013, Zalicus (formerly CombinatoRx Inc.) had $18 million in cash.
Epirus' lead product is BOW-015, a biosimilar version of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). Early next year, Epirus plans to start a European Phase III trial of BOW-015. The company submitted a regulatory application for BOW-015 in India in November and in January said it would submit applications in "targeted emerging markets" over the next 12 months. Zalicus' only clinical-stage product is Z944, a T-type calcium channel blocker that has completed Phase I testing for pain. 5AM Ventures' Scott Rocklage, an Epirus director, said Epirus does not plan on continuing internal development of Z944 but may out-license the product.
The boards of both companies have approved the deal, which is subject to approval by shareholders of both companies. The deal is slated to close this summer. Leerink is advising Epirus and Wedbush PacGrow is advising Zalicus, which was up $0.32 (31%) to $1.35 on Wednesday.
Chinese biologics company Livzon Mabpharm Inc. (Zhuhai City, China) led Epirus' B round. New investors Adage Capital; Greenwoods Investment; Gibralt U.S. Inc., part of Gibralt Capital; Monashee Capital Partners; and an affiliate of Mousse Partners also participated, along with existing investors TPG Biotech; Montreux Equity Partners; and 5AM Ventures. Livzon CEO Daotian Fu will join Epirus' board.
Pharmacogenetics company Foundation Medicine Inc. (NASDAQ:FMI) withdrew a proposed follow-on, citing market conditions. The company filed to raise $150 million in the offering last month, when its share price was $39.43. Goldman Sachs and JPMorgan were underwriters.
Foundation Medicine is the second biotech this month to withdraw a proposed follow-on citing market conditions. Earlier this month, Karyopharm Therapeutics Inc. (NASDAQ:KPTI) withdrew plans to to raise up to $115 million in an offering.
Foundation markets genomic profiles to identify treatment options and clinical trials for cancer patients, including FoundationOne for solid tumors and FoundationOne Heme for hematologic cancers, sarcomas and pediatric cancers. At Dec. 31, 2013, the company had $124.3 million in cash. The company had 2013 revenues of $29 million.
Foundation Medicine was up $2.21 to $27.18 on Wednesday.
Liver disease company Vital Therapies Inc. (NASDAQ:VTL) raised $54 million through the sale of 4.5 million shares at $12 in an IPO underwritten by BofA Merrill Lynch; Credit Suisse; William Blair; and Canaccord. The price values Vital at $253.4 million. The share price is below the range set earlier this month, when the company said it planned to 4.5 million shares at $13-$15. Vital is slated to start trading on Thursday.
Vital's human liver cell-based extracorporeal liver assist device (ELAD) is in the Phase III VTI-208 trial to treat alcohol-induced liver decompensation (AILD), with data expected in 1H15. This half, Vital also plans to start the Phase III VTI-210 trial for severe acute alcoholic hepatitis (AAH). The device is a bio-artificial liver system comprising a cartridge of membranes separating immortalized human C3A hepatoblastoma cells from a patient's plasma, which circulates through the device.
Wilson Therapeutics AB (Stockholm, Sweden) raised an undisclosed amount in a tranched $40 million series B round co-led by new investors Abingworth and MVM Life Science Partners. Existing investor HealthCap also participated. Wilson's WTX101 is in Phase I testing to treat Wilson's disease, a rare hereditary condition that leads to accumulation of toxic levels of copper. WTX101 is a second-generation analog of ammonium tetrathiomolybdate. Abingworth's Genghis Lloyd-Harris and MVM's Bali Muralidhar will join Wilson's board (see BioCentury, Aug. 13, 2012).
Iconic Therapeutics Inc. (Atlanta, Ga.) closed a $20 million series B round from new investors MPM Capital; Lundbeckfond Ventures; and H.I.G. BioVentures. Iconic is planning a Phase II trial of hI-con1 to treat wet age-related macular degeneration (AMD), but the company declined to disclose a timeframe for the start. The product is a human chimeric, IgG-like homodimeric protein composed of a targeting domain (mutated, inactive factor VIIa) fused to an effector domain (Fc portion of IgG). MPM's William Greene became CEO of Iconic. He succeeds co-founder Kirk Dornbush, who will become president and COO and will remain on Iconic's board. MPM's Todd Foley, H.I.G.'s Bruce Robertson and Lundbeckfond's Johan Kordel will join Iconic's board.
ForSight Vision5 Inc. (Menlo Park, Calif.) raised $15 million in a series C round led by new investor H.I.G. BioVentures. Existing investors Morgenthaler Ventures; Versant Ventures; Technology Partners; and Delphi Ventures also participated. H.I.G.'s Aaron Davidson will join ForSight Vision5's board.
ForSight Vision5's Helios ocular insert is in a Phase II trial to treat glaucoma and ocular hypertension, with final data expected later this year. Helios delivers bimatoprost, a prostaglandin analog, over multiple months.
Microlin Bio Inc. (New York, N.Y.) amended its IPO on NASDAQ and now plans to sell 2.7 million shares at $10-$12. At the $11 midpoint, the company would raise $30 million and be valued at $75.1 million. Brean Capital and Summer Street Research Partners are underwriters. In January, Microlin Bio filed to raise $25 million through the sale of a to-be-determined number of shares at $6-$8.
Microlin Bio is developing a pipeline of microRNA therapies, including lumiralin, a compound against miR-21 in preclinical development for lung cancer. The company has an exclusive license from Ohio State University to a portfolio of about 100 issued and pending patents and patent applications covering miRNAs.
Cancer companies BioAlliance Pharma S.A. (Euronext:BIO) and Topotarget A/S (CSE:TOPO) will merge in a stock deal to create a company focused on Orphan cancers. Topotarget shareholders will own about a third of the combined company, and BioAlliance shareholders will own the balance. BioAlliance CEO Judith Greciet will be CEO of the combined company, which will retain BioAlliance's name and will be dual listed on Euronext and NASDAQ OMX. BioAlliance Chairman Patrick Langlois will be chairman of the combined company.
Topotarget's Beleodaq belinostat is under Priority Review by FDA for relapsed or refractory peripheral T cell lymphoma (PTCL), with an Aug. 9 PDUFA date. Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) has North American and Indian rights to belinostat from Topotarget. BioAlliance's pipeline includes Livatag doxorubicin Transdrug (BA-003), which is in a Phase III trial for hepatocellular carcinoma (HCC), with data expected in 2016. BioAlliance also has two approved non-cancer products: Sitavig acyclovir Lauriad for recurrent orofacial herpes; and Oravig/Loramyc miconazole for oropharyngeal candidiasis. BioAlliance had 2013 sales of EUR 1.5 million ($2 million), while Topotarget had DKK8.3 million ($1.5 million) in revenues for the year.
The boards of both companies have approved the deal, which is still subject to BioAlliance and Topotarget shareholder approval. The deal is slated to close in July or August. Centerview Partners and Nordea are advising BioAlliance, and ABG Sundal Collier is advising Topotarget.
Topotarget gained DKK0.41 (14%) to DKK3.42 on Wednesday. BioAlliance was off EUR 0.03 to EUR 7.13.
Personal genomics company 23andMe Inc. (Mountain View, Calif.) hired Jill Hagenkord as CMO, a newly created position. She was SVP of medical strategy at genetic diagnostics company Invitae Corp. (San Francisco, Calif.). Prior to that, Hagenkord was SVP and CMO at Complete Genomics Inc., which genomics company BGI (Shenzhen, China) acquired.
In December, 23andMe discontinued consumer access to its health-related genetic testing after FDA ordered the company to immediately discontinue marketing its Personal Genome Service "for medical device uses" (see BioCentury, Dec. 9, 2013).
Baxter International Inc. (NYSE:BAX) said on-demand treatment with IV BAX 111 given with or without the company's Advate octocog alfa met the primary endpoint in an open-label Phase III trial to treat von Willebrand disease (vWD). On-demand BAX-111 led to treatment success for treated bleeding episodes in 100% of the 22 patients who experienced bleeds during the trial. There were no reports of inhibitor development or thrombotic events. The trial enrolled 37 patients with severe hereditary vWD.
By year end, Baxter plans to submit a regulatory application to FDA for BAX 111 as an on-demand treatment for vWD. BAX 111 is a recombinant human von Willebrand factor (vWF).
Baxter, which is splitting its medical products and biopharmaceuticals businesses into two public companies, was up $0.09 to $73.45 on Wednesday (see BioCentury Extra, March 27).
BHV Pharma Inc. (Research Triangle Park, N.C.) and Islet Sciences Inc. (OTCBB:ISLT) reported data on Wednesday from a pair of double-blind, dose-ranging Phase IIb trials evaluating remogliflozin etabonate (BHV091009) in treatment-naïve patients with Type II diabetes. In the first trial, all doses of twice-daily remogliflozin reduced HbA1c from baseline to week 12, the primary endpoint (reductions of 1-1.4%, p<0.001 for the dose response). In the second trial, once-daily remogliflozin at doses above the lowest dose tested reduced HbA1c from baseline to week 12 (reductions of 0.5-0.8%, p<0.047 for the dose response). Data from both trials will be presented at the American Diabetes Association meeting in June.
BHV and Islet Sciences have developed a once-daily formulation of remogliflozin designed to maintain the efficacy of twice-daily dosing and the safety of once-daily dosing. The companies could not be reached for next steps with the new formulation. Remogliflozin is also in Phase II testing to treat non-alcoholic steatohepatitis (NASH).
BHV has exclusive rights outside of Japan, Korea and Taiwan to develop and commercialize remogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, from Kissei Pharmaceutical Co. Ltd. (Tokyo:4547). Last month, Islet Sciences signed a letter of intent to acquire BHV in a stock deal.
The Arizona Senate passed a bill that would allow physicians to prescribe investigational products to eligible terminally ill patients who have no "comparable or satisfactory" FDA-approved treatment options. The bill would prohibit the state from taking any action against a doctor or health care institution that prescribes or treats a patient with an investigational treatment, defined as a drug, biologic or device that has completed Phase I testing but does not have FDA approval. The Arizona House of Representatives has already passed the bill, which now goes to Gov. Janice Brewer. If she does not veto the bill, it will be subject to voter approval in the state's November general election.
Similar bills are moving through the legislatures of at least two other states: Louisiana and Missouri.
Last week, Rep. Morgan Griffith (R-Va.) introduced in the U.S. House of Representatives the Compassionate Freedom of Choice Act, which would allow manufacture, importation, distribution, and sale of investigational products outside of a clinical trial for terminally ill patients without restriction by or reporting to FDA. The bill, H.R. 4475, was referred to the House Energy and Commerce Committee.
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