Positive Phase III results for its heart failure drug BiDil certainly played a role in NitroMed Inc.'s ability to raise almost $80 million in a public offering on Wednesday.
The Lexington, Mass.-based company brought in about $15 million more than it had set out to raise last month, when it provided detailed results of BiDil at a scientific meeting. Strong preliminary data caused the company to stop the trial early last summer, and sent the stock soaring 73 percent. (See BioWorld Today, July 20, 2004.)
The public offering of 3.25 million shares at $24.46 apiece will support a launch of BiDil as a heart drug targeted to treat African-Americans. While it's difficult to know when or if the FDA will approve the product, NitroMed will be ready to launch it as early as the end of the first quarter.
"It's expensive to launch a product, especially a cardiovascular product," said Michael Loberg, NitroMed's president and CEO. "We're pleased that we were able to raise this significant amount of money."
Though the offering grossed about $79.6 million, NitroMed expects to receive net proceeds of $74.2 million to cover general corporate purposes, in addition to a potential BiDil launch. The company is granting the underwriters an option to purchase up to 431,581 shares for overallotments. If exercised, the overallotment option would add another $10.6 million gross to the company's coffers.
The underwriters are JP Morgan Securities Inc. and Pacific Growth Equities LLC, both of San Francisco, which are acting as joint book-running managers. Deutsche Bank Securities Inc. and Bear Stearns & Co. Inc., both of New York, are acting as co-managers.
Even before the detailed Phase III results, this summer analysts were estimating that BiDil could bring in more than $120 million in 2005, and in the range of $350 million in 2008.
NitroMed acquired BiDil's new drug application and related intellectual property in 1999. An NDA originally was filed by Medco Research, a company later acquired by King Pharmaceuticals Inc., of Bristol, Tenn. The FDA rejected that NDA, which sought approval of BiDil as a heart drug for the general population.
"We had a chance to acquire that NDA and to examine it, and it turned out that, indeed, BiDil provided a very limited cardiovascular benefit to non-African-Americans," Loberg told BioWorld Today.
The data, however, showed a strong benefit for African-Americans over other ethnic groups, possibly due to the underlying pathophysiology of heart failure.
In 2001, the FDA requested that NitroMed conduct a confirmatory Phase III trial. The results of that trial, presented in detail in November, showed that BiDil yielded a 43 percent survival improvement when given with standard heart failure therapy, as compared with patients who received the standard therapy plus placebo. Results also showed the therapy reduced hospitalization by 33 percent, and it improved quality of life for the African-American heart failure patients taking BiDil. (See BioWorld Today, Nov. 9, 2004.)
NitroMed is in the process of building a sales team. With district and regional managers already on board, the company expects to have between 175 and 200 people to promote BiDil.
"We have always been a company whose business model has been limited to royalties and milestones," Loberg said. "And so we would be transitioning from that sort of business model into a true operating company that would have marketing and sales skills, as well."
BiDil consists of two generic drugs, isosorbide dinitrate and hydralazine, neither of which is approved for heart failure.
Behind BiDil, NitroMed has a COX-2 inhibitor program that recently was dropped by Whitehouse Station, N.J.-based Merck & Co. Inc., in lieu of that company's withdrawal from worldwide markets of its own COX-2 painkiller, Vioxx, which was pulled from the market due to data showing a higher risk of heart attack and stroke in patients taking the compound for 18 months or more.
NitroMed's main focus for the coming year will be on a BiDil launch. The amendment to the NDA should be filed by the end of this year.
NitroMed conducted its initial public offering for $66 million in November 2003. Its stock (NASDAQ:NTMD) rose 9 cents on Wednesday to close at $24.55.
On File For An IPO, Targacept Raises $33M
A total of four other companies raised a combined $79.4 million on Wednesday, led by privately held Targacept Inc., of Winston-Salem, N.C., which closed a $33 million financing with existing investors.
Targacept intends to use the proceeds from its financing, which was led by London-based Nomura Phase4 Ventures, for the clinical development of its lead product candidates.
The company is focused on a new class of drugs to treat multiple diseases and disorders of the nervous system by selectively targeting neuronal nicotinic acetylcholine receptors (NNRs). They are found on nerve cells and serve as key regulators of nervous system activity. Targacept's products selectively target specific NNR subtypes.
The 73-person company has one marketed product, Inversine, and four candidates in clinical development, as well as several others at the preclinical stage. The pipeline includes TC-1734 in Phase II for cognitive impairment in elderly persons, TC-5231 in Phase II for attention deficit hyperactivity disorder, TC-2403 in Phase II for ulcerative colitis and TC-2696 in Phase I for pain.
Founded originally as a subsidiary of R.J. Reynolds Tobacco Co., Targacept became an independent company in August 2000. It filed in May for its IPO to raise $86.25 million but has yet to price. (See BioWorld Today, May 18, 2004.)
Amphora Brings In $20M In VC Funding
Amphora Discovery plans to use its $20 million to advance drug discovery programs for its partners and to accelerate the preclinical development of the company's internal candidates.
The round was led by the 3i Group and included new investors Switzerland-based Novartis Venture Fund and France-based Aventis Capital, as well as existing investors, ARCH Venture Partners, of Chicago; MPM Capital, of Boston; Venrock Associates, of New York; and Versant Ventures, of Menlo Park, Calif.
Amphora has a pathway-based drug discovery approach to find therapeutics for oncology, inflammation, metabolic disease and neurological disorders. Two of the company's most-advanced preclinical compounds are specific inhibitors for AKT1 and p38A to treat oncology and inflammatory indications, respectively.
In March, Amphora entered a two-year research agreement with Aventis SA (now part of the Sanofi-Aventis Group, of Paris) to focus on chemical biology and lead generation. Amphora is searching for small-molecule kinase inhibitors for multiple potential therapeutic targets. Aventis agreed to pay Amphora research funding, milestones and royalties on future products.
The company, which was spun out of Caliper Technology Corp., of Mountain View, Calif., raised $25 million in its Series A round completed in 2001. It raised $23 million in its Series B, which was conducted a year later. (See BioWorld Today, Dec. 31, 2002.)
Biomira Seeking Funds After Stock Jump
While Biomira's financing has not yet closed, the company hopes to use the $10 million for the next phase of clinical testing of its BLP25 liposome vaccine to treat non-small-cell lung cancer.
News of the funding comes less than a week after the company released positive Phase IIb results.
Rodman & Renshaw LLC, of New York, is acting as exclusive placement agent of the financing, which will draw down shares from a $100 million shelf registration filed in the U.S. and Canada in July.
Biomira is offering up to 3.9 million common shares at $2.57 each, a discount of 15 percent to the company's closing U.S. stock price of $3.02 Tuesday. The stock (NASDAQ:BIOM) dropped 48 cents on Wednesday to close at $2.54 in the U.S.
The issue includes up to 778,210 purchaser warrants. Each purchaser will receive 0.20 warrants for every common share purchased, and each warrant will entitle the holder to purchase one common share at $3.45. The three-year warrants may not be exercised for six months following closing of the offering.
Biomira's stock soared 114.3 percent on Friday on positive Phase IIb data of the BLP25 liposome vaccine that showed a huge survival benefit for Stage IIIB non-small-cell lung cancer patients. At the 23-month mark, the subset of locoregional Stage IIIB patients in the vaccine arm still had not reached median survival, while patients in the control arm had a median survival of 13.3 months. BLP25, which is partnered with Darmstadt, Germany-based Merck KGaA, incorporates a 25-amino-acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system.
The company expects to start a Phase III trial in late 2005.
Introgen Gets $16.4, Mostly From Two Investors
Introgen placed about 2.5 million shares of its common stock, raising the majority of the $16.4 million through two large European institutional investors.
London-based Mulier Capital acted as placement agent for the financing, which provides the company with additional resources for its Advexin registration program, as well as other clinical programs.
The financing was conducted as part of a shelf registration filed in August 2003.
In November, Introgen published data in The Laryngoscope from preclinical studies evaluating the impact of Advexin in combination with chemotherapy on head and neck cancer tumor cells. The combination increased the expression of p53, decreased the expression of several genes that drive cell growth and division, and increased the expression of genes that cause cancer cells to die.
Advexin combines the p53 gene with a non-replicating, non-integrating adenoviral gene-delivery system developed by Introgen. The product currently is in Phase III trials for patients with recurrent head and neck squamous-cell carcinoma. The company has fast-track and orphan drug designation for Advexin, which also is in Phase I and Phase II trials in a variety of other cancers, including breast, prostate and non-small-cell lung cancers.
Aside from Advexin, Introgen is studying INGN 241, INGN 225 and INGN 401 for a variety of cancer indications. Those products are in early clinical trials.
Introgen's stock (NASDAQ:INGN) dropped 5 cents on Wednesday to close at $7.65.