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WEEK OF AUGUST 15, 2011 BioCentury THE BERNSTEIN REPORT ON BIOBUSINESS Volume 19 • Number 34 • Page A1 of 21 Finance Rebalancing act By Stacy Lawrence BioCentury This Week Senior Writer Companies in the midst of launching Cover Story Daclizumab in MS — The first look at the products or with weak balance sheets have been sold off or avoided by most Rebalancing Act — The market turmoil Select data for daclizumab from Biogen Idec and Abbott, and how the once-monthly sub- investors during the market roller-coaster saw investors scorch biotechs with product of the past two weeks. However, a hand- launches or weak balance sheets, but some cutaneous approach compares to the mar- keted and Phase III competition./A13 ful of companies have been insulated specialists exploited the opportunity to clean from the carnage — their common up portfolios and go shopping for value plays. threads being strong sales, pending or Emerging Company Profile potential acquisitions, or positive data. Strategy Cancer Stem Cell Engine — Verastem Large caps as a group also held up believes it can produce an almost unlimited relatively well. New Vision — After failing to capitalize on the In the last two weeks, the NASDAQ approval of its first drug followed by a share- number of stem-like cells to use as screens for small molecules against CSCs./A15 Biotechnology Index (NBI) fell 13%. The holder revolt, InSite has raised money to refocus BioCentury 100 was off 12%, while the on four ophthalmology programs it thinks can NYSE Arca Biotechnology Index (BTK) Finance be moved through the clinic quickly./A5 lost 17%. Over the same time, the S&P Ebb & Flow — Flurry for Forest finale. Pulmatrix 500 and the NASDAQ were both off Product Discovery & Development has CALM investors. Vaxxas patches up nicely. 9%, while the Dow Jones Industrial Av- erage shed 7% (see “Seeing Red,” A2). Powering Down Cancer — The first Also: BMO; Adventrx; Affymax; Amylin; Arena; A sliver of good news emerged on data are beginning to emerge from a cluster MannKind; Pharmasset, et al./A16 Thursday and Friday last week — the of companies targeting the energy needs of NBI, BC100 and BTK each gained 6% malignant cells, based on a better under- Featured links this week/A18 over the two days — as biotechnology standing of why cancer cells use altered Stock charts & tables/A21 buysiders started shopping for discounts metabolic pathways./A6 Company index/A4 on companies with strong fundamentals Locking in Lebrikizumab — In the race to and balance sheets. treat asthma with anti-IL-13 molecules, BioCentury 100TM Indicators See next page Genentech now has positive Phase II data and Week ended 8/12/11 a biomarker for responders to lebrikizumab. PRICES VOLUME Next up are data from MedImmune’s 2130.98 1154.9M shrs tralokinumab./A11 This Week on BioCentury TV up 1% up 3% America’s Health Advisor — IOM gets the hard questions. Please see Program Notes on A3. www.biocenturytv.com This Week in SciBX Bromodomain Brake on AML — Tensha Therapeutics hopes to bring a bromodomain inhibitor into Phase I trials after a Cold Spring Harbor-led team used the strategy to treat NewsMakers Expands AML in mice. Please see Table of Contents on A11. More names are added to the presenting company roster at the 18th Annual BioPharm America Soon NewsMakers in the Biotech Industry conference. Pre-conference partnering has started. Please see announcement following A21. Please see announcement following A21. BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS AUGUST 15, 2011 PAGE A2 OF 21 Finance, sales of Incivek, half from stocking and half their launch.” from previous page from end user sales. The numbers beat InterMune plans to launch Esbriet pir- analyst estimates for end user sales, which fenidone in Europe in September to treat were $31-$35 million. idiopathic pulmonary fibrosis. In March, Lumps on launch Upcoming and ongoing launch stories HGS and partner GlaxoSmithKline plc Almost every buysider contacted by also had the poorest showings in the $1- launched lupus drug Benlysta belimumab BioCentury noted the punishment of com- $4.9 billion segment. Among the top in the U.S. Human Genome reported $7.8 panies with recent or upcoming launches. decliners is Savient Pharmaceuticals million in 2Q sales, its first full quarter. The start of the market slide coincided Inc., which launched gout drug Krystexxa The consensus estimate was $8.5 million. with scaled down expectations for pegloticase in December. The stock was One biotech mutual fund manager who Dendreon Corp.’s Provenge prostate down $2.72 (39%) to $4.28 in the last two asked to remain anonymous also cited cancer vaccine following the company’s weeks after revenues missed consensus Human Genome and InterMune, adding 2Q call, which investors have taken as a estimates. Seattle Genetics Inc. to the list as well. bad indicator for biotech launches (see Other big drops in the $1-$4.9 billion Seattle Genetics dropped $3.10 (17%) BioCentury, Aug. 8). market cap band were InterMune Inc., to $13.93 in the last two weeks. The Indeed, Dendreon was the worst per- which was off $10.44 (31%) to $22.94, company has an Aug. 30 PDUFA for former among biotechs valued above $5 and Human Genome Sciences Inc., Adcetris brentuximab vedotin to treat billion. The stock shed $26.53 (72%) to which shed $5.33 (25%) to $15.68. Hodgkin’s lymphoma and systemic ana- $10.37 in the past two weeks. “Any company with high-priced drugs plastic large cell lymphoma. In July, FDA’s “Obviously the product launch stories and a phenotype like Dendreon has been Oncologic Drugs Advisory Committee suffered the most post-Dendreon,” hit. Investors are now very concerned that recommended accelerated approval. summed up David Chan of Jennison Asso- launches are even more risky than be- Joep Muijrers of LSP is actually buying ciates. fore,” said Kurt von Emster of venBio. into some launch stories now. Even Vertex Pharmaceuticals Inc. “InterMune will have a high-priced drug “Following Dendreon’s setback, which was off $7.37 (14%) to $44.49 in the same launching in Europe soon. Human Ge- we believe came at the worst possible time period, despite a positive launch for HCV nome Sciences continues to be under in light of prevailing market conditions, it drug Incivek telaprevir. pressure, although they have done a good seems as if people are now questioning the Vertex reported $74.5 million in 2Q job tempering investor expectations about entire therapeutic biotech model. We do not mind being on the other side of that bet,” he said. Seeing red Bad clinical and regulatory news was responsible for the worst performances in For the past two weeks, biotechs across the board have been battered even more than the overall markets. three market cap segments under $1 bil- Companies in the small to mid-cap ranges sustained the most damage, dropping more than 16%. lion. The BioCentury 100 was down 12% for the past two weeks while the Dow and S&P 500 fell 7% and In the $500-$999 million group, Ac- 9%, respectively. The Amex Pharmacuetical Index shed 7.4% tive Biotech AB’s oral laquinimod missed the primary endpoint in a Phase III trial to Companies are grouped into market cap tiers as of July 29. Median percentage changes calculated treat relapsing-remitting multiple sclerosis for each market cap segment from July 29 through Aug. 12. Advancers-decliners are in brackets. (RRMS). The results were announced on Aug. 1, and Active Biotech was down SEK45.15 (57%) to SEK33.60 in the last two weeks. The compound is partnered >=$5B≥ -9.6% [0-18] with Teva Pharmaceutical Industries Ltd., which fell $6.94 (15%) to $39.70 during the period. In the $200-$499 million segment, $1B-$4.9B -11.5% [3-44] Insmed Inc.’s Arikace to treat Pseudomo- nas aeruginosa infection in patients with cystic fibrosis (CF) was placed on clinical hold by FDA on Aug. 2. The stock was $500M-$999M -16.4% [1-47] down $7.04 (61%) to $4.45 over the past two weeks. Adventrx Pharmaceuticals Inc. was the worst performer in the last two weeks $200M-$499M -16.9% [4-93] among the biotechs valued under $200 million. It was down $1.89 (64%) to $1.06 on last week’s complete response letter for Exelbine vinorelbine injectable emulsion to <$200M -12.2% [36-291][37-290] treat non-small cell lung cancer (NSCLC). FDA said the company’s trial needs to be repeated to verify the authenticity of the -20% -10% 0% 10% drug product used (see B9). See next page BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS AUGUST 15, 2011 PAGE A3 OF 21 Finance, $3.65 to $125.03 after a 2-for-1 stock split from previous page “With some of the oncology within the last two weeks. Investors re- main enthusiastic about its oral HCV pro- On the heels of recent IPOs, genomics and neurology names down gram. In contrast, competitor Idenix companies Pacific Biosciences of Cali- since May, we are now Pharmaceuticals Inc. fell $2.52 (38%) fornia Inc. and Complete Genomics to $3.16. Inc. were off on weak 2Q earnings. Pacific buying them back, in some Biosciences dropped $5.05 (46%) to $5.96, cases fairly aggressively.” while Complete Genomics lost $3.77 (30%) Biotech cycles to $8.62. Kurt von Emster, venBio Many biotech buysiders are using the market’s gyrations to rotate within the sector, but say they won’t pull the trigger Finding shelter Luminex Corp. and Genmab A/S on a stock purchase unless the company A handful of biotechs have weathered were the top performers in the $500-$999 has a strong cash position.
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