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In recent market rally, the biotechs have seen some major moves. Many of the drugs and biotechs related stocks have seen 300% plus moves in compressed time frame.
This has attracted lot of investors and traders to focus on them. The biotechs have a unique trading pattern. Understanding how a specific industry trades can provide you with an edge. Most of these stocks have no sales, no earnings and when the sector is in favor they make 100 plus moves in jiffy.
Biotechs is pure speculative game. One can make lot of money in it if one manages risk properly. Some of the things I have found over the years by trading biotechs are:
- Episodic Pivots are best to time entries in biotechs. Most biotech moves are precipitated by some news events.
- The sector gets in favor and out of favor. Mostly these things are also linked to decision cycle by FDA. When sector is in favor the more speculative ones pop one after another.
- One must buy the first breakout and on first day. It is pointless to buy second breakout. One must put full position at beginning itself. The rallies in these names are so compressed that in few days or week they make bulk of their move. So either you are in or you are a spectator.
- In most cases there is one intense 10 to 30 days burst followed by long sideways move, which invariably fails. It looks very attractive like a flat base and often has upside breakout which fails. I normally liquidate my position in 20 to 22 days in such plays.
- Insider buying on biotechs is very good indicator.
- Playing biotech is like playing lottery. There is very high risk.
Cytokinetics’ Cardio Bet Pays Off with Amgen Option Exercise
Cytokinetics Inc.’s decision to scrap its internal oncology programs and focus on heart failure drug CK-1827452 is looking pretty smart now that partner Amgen Inc. exercised its option on the drug, triggering a $50 million payment to Cytokinetics. Amgen will cover all future expenses, including two ongoing Phase IIa trials, unless Cytokinetics elects to shoulder a portion of the Phase III costs in exchange for a co-promote option. The deal is expected to leave Cytokinetics with about two years worth of cash, much of which the biotech plans to plough into preclinical programs.
MAP Reports Positive Phase III Migraine Study
MAP Pharmaceuticals Inc. reported that its first Phase III trial of Levadex, an orally inhaled migraine therapy, met all four primary endpoints, data that sent its shares soaring by 180 percent in midday trading Tuesday. Additional endpoints showed that the drug candidate provided rapid and sustained pain relief for up to 48 hours after dosing.
UTC’s Shares Rise on Adcirca Approval in PAH
Shares of United Therapeutics Corp. rose 11 percent in morning trading Tuesday after the Silver Spring, Md.-based firm said the FDA approved Adcirca (tadalafil) as the first once-daily oral phosphodiesterase type 5 inhibitor for the treatment of pulmonary arterial hypertension, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. The drug, a 40-mg dosage form of tadalafil, which is marketed at lower dosage forms by Eli Lilly and Co. as Cialis to treat erectile dysfunction, is expected to be a strong competitor against Pfizer Inc.’s PAH drug Revatio (sildenafil citrate).
Cancer, Depression Have Direct Link in Cytokines, Corticosterone
Few people will find it surprising that cancer patients tend to be vulnerable to depression. If a potentially deadly disease is not enough, the ravages - and side effects - of chemotherapy also can be highly disruptive. But there is an increasing understanding that cancer also contributes to a vulnerability to depression directly, through physiological mechanisms. In the May 18, 2009, early online edition of the Proceedings of the National Academy of Sciences, researchers from the University of Chicago demonstrated a direct physiological link between cancer and depression, and described its mechanism.
Also in the News:
4SC, Allos Therapeutics, Amarin, Amgen, Astex, Astrazeneca, Beactica, Bioniche, Bristol-Myers Squibb, Cell Genesys, Celleron Therapeutics, Cel-Sci, Chugai Pharmaceutical, Cortex, Cubist Pharmaceuticals, Cytheris, Cytopia, Emisphere Technologies, FIT Biotech, Gene Bridges, Generex Biotechnology, Haemacure, Hemispherx Biopharma, ImmunoVaccine Technologies, KineMed, Logical Therapeutics, Lux Biosciences, Medinox, NanoViricides, Oscient Pharmaceuticals, Prospect Therapeutics, Senesco, Spectrum Pharmaceuticals, Vaxart, Vical, Viropharma
Oxford BioTherapeutics, GSK Partner in $370M Cancer Drug Dea
UK biotech Oxford BioTherapeutics stands to gain $370 million under a new partnership with drug giant GlaxoSmithKline plc to discover, develop and commercialize therapeutic antibodies aimed at treating primary, metastatic and recurring forms of cancer. The deal represents OxFord’s transition from a discovery firm to a drug development company, said CEO Christian Rohlff.
Takeda Taking Over IDM Pharma for $66.7M
Takeda Pharmaceutical Co. Ltd.’s planned takeover of IDM Pharma for $66.7 million brings IDM back from the brink of Nasdaq delisting, and gives the Irvine, Calif.-based firm more clout as it works to win FDA approval of Mepact (mifamurtide). Already approved in Europe as an orphan drug, the osteosarcoma therapy is what brought Takeda to the table, and the Japan-based pharma giant paid a 55 percent premium to IDM’s Friday closing stock price.
Biovail to Buy Tetrabenazine Products for $230M
Biovail Corp. is buying development and marketing rights to the entire portfolio of tetrabenazine products from Ireland’s Cambridge Laboratories Ltd. for $230 million. The deal will generate in the range of $23 million to $26 million in revenues in 2010. Upon closing of the transaction, Biovail will earn revenue from the worldwide sales that have been established through Cambridge’s network of marketing partners in approved territories.
Onyx Sues Bayer over Alleged Nexavar Alternative
Onyx Pharmaceuticals Inc.’s lawsuit against Nexavar partner Bayer AG put the damper on speculation about a possible merger. The complaint alleges that Bayer is surreptitiously developing an alternative to Nexavar (sorafenib) for liver cancer, as Bayer is not satisfied with the way the market compound’s profits are divvied up. Bayer, according to Onyx, is pushing fluoro-sorafenib along under a separately filed patent, and does not plan to recognize it as a product covered by the two firms’ collaboration.
Sciele Picks up Victory Pharma for $150M
Sciele Pharma Inc. added several pain products to its cardio and diabetics portfolio in a $150 million cash purchase of privately held Victory Pharma Inc. The purchase includes Victory’s lead product, Naprelan, the only branded, once-daily sustained-release formulation of naproxen sodium, a nonsteroidal anti-inflammatory drug.
Also in the News:
A.P. Pharma, Argenta Discovery, AstraZeneca, Basilea, Biopure, Clinical Data, Daiichi Sankyo, DeCode, Essentialis, InDex Pharmaceuticals, InterMune, Light Sciences Oncology, Lonza Biologics, MorphoSys, Northfield Laboratories, Novartis, Oncogene, Optimer Pharmaceuticals, Promosome, Provectus, Rexahn, Sol-Gel Technologies, Sunesis Pharmaceuticals, Trius, Vical
Acadia Climbs 150% on $395M Pimavanserin Deal with Biovail
Shares of Acadia Pharmaceuticals Inc. gained 150 percent in midday trading on Monday after the company unveiled a surprise partnership with Biovail Corp. for North American rights to its lead drug, pimavanserin. The deal may bring Acadia $30 million up front and $365 million in milestone payments, as well as royalties, and the biotech retained ex-North American rights as well as a co-promote option. Investors hadn’t expected to see a pimavanserin partnership until after the drug completes its two ongoing Phase III trials in Parkinson’s disease psychosis.
Pharmaxis Hits the Mark in Phase III Cystic Fibrosis Trial
Pharmaxis Ltd. reported positive results from a Phase III study of Bronchitol in cystic fibrosis patients, one of the largest clinical trials conducted in that disease. Patients treated with Bronchitol had a statistically significant improvement in lung function compared to placebo. Lung function improved at week six and was sustained through to week 26.
WHO not Ready to Declare Full-Blown Pandemic
Officials from the World Health Organization, which reported Monday that the H1N1 swine-origin Influenza A virus has infected 1,025 people worldwide, said they were concerned about the spread of the virus to the Southern Hemisphere – which is entering its winter months, when influenza viruses typically thrive – and countries in Europe and Asia, but is not yet ready to declare a full-blown pandemic. Meanwhile, the FDA and the Federal Trade Commission said they were cracking down on companies selling phony swine flu cures.
Ironwood Getting $40M Up Front in European Linaclotide Deal
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., partnered its constipation drug linaclotide overseas in a deal with Laboratorios Almirall SA in exchange for $40 million up front plus another $15 million in near-term equity. Beyond that, the agreement calls for additional milestones and royalties on product sales, with Ironwood eligible to receive about half the long-term value of the product upon successful commercialization. Linaclotide, which is partnered with Forest Laboratories Inc. in a co-develop U.S. arrangement, is in pivotal testing in chronic constipation and is set to start Phase III trials in irritable bowel syndrome with constipation.
Also in the News:
Arno Therapeutics, Becton Dickinson, Clinical Data, CombinatoRx, Discovery Labs, Fovea, Fujirebio Diagnostics, Haemacure, Inspire, Invitrogen, Kamada, NeoStem, Peregrine Pharmaceuticals, Pulmatrix, Rexahn, SemBioSys Genetics, Sirona Biochem, SuperGen, TransMolecular, Tranzyme Pharma
VIA Pops on Subset Analysis from Phase II ACS Trial
Shares of VIA Pharmaceuticals Inc. jumped 50 percent in midday trading Friday after the company presented a subset analysis from its Phase II trial of VIA-2291 in acute coronary syndrome. The trial previously met its primary endpoint of significantly inhibiting Leukotriene B4 production. The subset analysis showed that patients receiving longer treatment with VIA-2291 had fewer new plaque lesions and lower plaque volumes than the placebo group.
AGTC Raises $11.8M to Fund Gene Therapy Trials
Applied Genetic Technologies Corp. has raised $11.8 million in a venture-funded financing round, providing the company with enough cash to complete efficacy trials for two of its gene therapy product candidates. The financing was led by InterWest Partners. Other participants in the round include Intersouth Partners and MedImmune Ventures Inc.
Washington News: H1N1 Flu and Botox
A top World Health Organization official today said it would be “too much of a gamble” for public health not to produce a vaccine against the 2009 H1N1 swine-origin influenza A virus. Meanwhile, the Department of Health and Human Services said it was buying 13 million more treatment courses of Tamiflu and Relenza to replenish the national stockpile and also sending 400,000 courses of the drugs to Mexico. In other Washington news, the FDA ordered the makers of botulinum toxin products to include a black-box warning about serious risks associated with the drugs.
Altruists vs. Profiteers: Whom Do You Root For?
In a fight between rich corporate raiders and the management of modestly sized biotech companies, all instincts are to side with the latter. As popularity contests go, it seems like a pretty uneven match-up. But in the growing number of battles between companies and activist investors, it’s often the Wall Street guys who have been coming out looking more reasonable than our homegrown champions of medical progress. Karl Thiel opines.
Northfield Falls on Complete Response Letter for PolyHeme
Shares of Northfield Laboratories Inc. were down 50 percent in morning trading after the Evanston, Ill.-based firm said it received a complete response letter for its blood substitute product, PolyHeme. In its letter, the FDA pointed to the fact that the company’s pivotal trial failed to meet its primary endpoint and noted safety data that indicated PolyHeme actually placed patients at a higher risk of adverse events.
Also in the News:
BioMarin, CSL Behring, Emisphere, Isis, Neurobiological Technologies, Novozymes, Oncolytics Biotech, Oxygen Biotherapeutics, ProMetic, Protein Sciences, RegeneRx, Tercica, Tigris Pharmaceuticals, United Therapeutics
What is swine flu?
Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza viruses that causes regular outbreaks in pigs.
What are the signs and symptoms of swine flu in people?
The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated withswine flu. Severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions.
How does swine flu spread?
Flu viruses are spread mainly from person to person through coughing or sneezing. Sometimes people may become infected by touching something with flu viruses on it and then touching their mouth, nose or eyes.
How can someone with the flu infect someone else?
Infected people may be able to infect others beginning one day before symptoms develop and up to seven or more days after becoming sick. That means that you may be able to pass on the flu to someone else before you know you are sick, as well as while you are sick.
How long can an infected person spread swine flu to others?
People with swine influenza virus infection should be considered potentially contagious as long as they are symptomatic, possibly up to seven days following illness onset. Children, especially younger children, might potentially be contagious for longer periods.
What can I do to protect myself from getting sick?
There is no vaccine available right now to protect against swine flu. There are everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza. Take these everyday steps to protect your health:
• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.
• Avoid touching your eyes, nose or mouth. Germs spread this way.
• Try to avoid close contact with sick people.
• If you get sick with influenza, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them. Try to stay in good general health. Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food. Try not touch surfaces that may be contaminated with the flu virus. Avoid close contact with people who are sick.
What surfaces are most likely to be sources of contamination?
Germs can be spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth. Droplets from a cough or sneeze of an infected person move through the air. Germs can be spread when a person touches respiratory droplets from another person on a surface like a desk and then touches their own eyes, mouth or nose before washing their hands.
How long can viruses live outside the body?
We know that some viruses and bacteria can live two hours or longer on surfaces like cafeteria tables, doorknobs, and desks. Frequent hand washing will help you reduce the chance of getting contamination from these common surfaces.
Are there medicines to treat swine flu?
Yes. CDC recommends the use of oseltamivir (tamiflu) or zanamivir (relenza) for the treatment and/or prevention of infection with these swine influenza viruses. Antiviral drugs are prescription medicines (pills, liquid or an inhaler) that fight against the flu by keeping flu viruses from reproducing in your body. If you get sick, antiviral drugs can make your illness milder and make you feel better faster. They may also prevent serious flu complications. For treatment, antiviral drugs work best if started soon after getting sick (within two days of symptoms).
If I am traveling, should I carry Tamiflu?
Consult with your medical provider. Consideration should be given to carrying Tamiflu, especially to areas where access to healthcare may be limited. Tamiflu, which can reduce symptoms if started within two days of onset, might be considered for patients who have:
• underlying chronic medical conditions such as heartdisease, diabetes, asthma, or a compromised immune system;
• had flu like symptoms for less than 48 hours.
Should travelers carry antibiotics?
Antibiotics are not effective against a flu virus. In some cases with severe influenza, antibiotics are used to treat complications of the flu such as bacterial pneumonia. But the selection of which antibiotics to use would require expert medical advice. A traveler who develops significant respiratory illness should seek medical care rather than self-treatment with oral antibiotics.
What should I do if I get sick?
If you become ill with influenza-like symptoms (e.g. fever, body aches, runny nose, sore throat, nausea, or vomiting or diarrhea), contact your health care provider, who can determine if influenza testing or treatment is needed. Stay home and avoid contact with other people as much as possible to keep from spreading your illness to others. Employees with significant respiratory illness or fever should not go to work. Notify your manager of the illness as well as your medical provider.
In children, emergency warning signs that need urgent medical attention include:
• Fast breathing or trouble breathing
• Bluish skin color • Not drinking enough fluids
• Not waking up or not interacting
• Being so irritable that the child does not want to be held
• Flu-like symptoms improve but then return with fever and worse cough
• Fever with a rash
In adults, emergency warning signs that need urgent medical attention include:
• Difficulty breathing or shortness of breath
• Pain or pressure in the chest or abdomen
• Sudden dizziness
• Confusion
• Severe or persistent vomiting
Should I travel to Mexico or other affected areas?
Neither the U.S. Center for Disease Control or the World Health Organization has issued travel health advisories. However, it is recommended that people postpone travel to affected areas at this time.
What is the risk of catching swine flu if I travel to or live in Mexico or other affected areas?
The risk is unknown but probably low. The disease is spread via respiratory secretions so good personal hygiene is important to reducing the risk.
What is the risk of contracting swine flu from exposure to travelers from an affected area?
Visitors who feel well should pose very little exposure risk. Swine flu in Mexico has shown human-to-human transmission. Visitors who feel ill or have a fever should not come to work to avoid the risk of spreading influenza or another viral illness and should seek medical attention.
Where do I get additional information?
www.cdc.gov
www.who.int/en
www.dhhs.gov/nvpo/pandemics/
www.cdc.gov/swineflu/swineflu_you.htm
Oral MS Drug Data a Mixed Bag at AAN
Two oral multiple sclerosis drugs – Merck Serono’s cladribine and Novartis AG’s FYT720 (fingolimod) – continued to show solid efficacy data but safety concerns prevented either one from emerging as a clear winner at the American Academy of Neurology meeting in Seattle. Both drugs met their primary endpoints in respective Phase III studies and are expected to be submitted for approval this year, yet some analysts say that, even in the increasingly crowded MS space, questionable safety profiles of newer drugs might not sway physicians from the more established – though possibly less efficacious – ABCR therapies.
Amylin, Lilly to Share Development Costs of Exenatide Pen for Diabetes
Amylin Pharmaceuticals Inc. and Eli Lilly and Co. have agreed to share the capital and development costs of exenatide in pen device form. Over the next few years, the two companies will share the initial capital investment of about $216 million, with Lilly making 60 percent of that investment. The firms also have initiated a Phase I/II study to examine a new exenatide once weekly suspension formulation. The trial began this month and initial findings are expected by the end of 2009.
H1N1 Vaccine Research Underway, but Nothing Decided on Production
The CDC has isolated a seed strain and is busy growing it for manufacturing of a vaccine against the 2009 H1N1 swine influenza, but has not yet distributed it to manufacturers, the acting head of the agency told reporters today. The current working plan, said Richard Besser, is to have manufacturers complete their production of seasonal influenza vaccines and then switch over to producing a vaccine against the new H1N1 strain, with a product available possibly by the fall. However, he said, the government’s current focus is ensuring a seasonal flu vaccine is available in adequate supplies for the 2009-10 season.
HIV Uses Endosomes, Not Direct Membrane Fusion, to Enter Cells
Among the ways to classify viruses is whether they need an acidic environment to fuse with the cells they infect. Some do, and some – most prominently HIV – don’t. Cells that need an acidic environment clearly enter into cells via endocytosis – that is, they are taken up when small parts of the cellular membrane pinch off and engulf them to form endosomes. In the May 1, 2009 issue of Cell, however, scientists show that HIV, too, enters cells through endosomes, rather than fusing with the host cell membrane directly.
Also in the News:
Aethlon, Alseres, Arrayit, Avexa, Basilea, Bayer, BioAxone, Biogen Idec, BioTime, Can-Fite, Coherix, CombiMatrix, Debiopharm, Energex Systems, ImmuneRegen, Ipsen, LifeCycle Pharma, Medicis, NeurogesX, Prometheus labs, Regeneron, Rockwell Medical, Rosetta Genomics, RXi Pharmaceuticals, Sepracor, Sequenom, XOMA, ZymoGenetics.
Oxford BioMedica Loses TroVax Partner but Gets New Sanofi Deal
Oxford BioMedica plc has to start shopping around for a new partner for its TroVax therapeutic cancer vaccine after Paris-based Sanofi-Aventis dropped the late-stage program as part of a sweeping pipeline makeover. But the good news is that the Oxford, UK-based firm signed a new deal with Sanofi to develop gene-based therapies for ocular diseases in exchange for $50 million in up-front and committed funding. And finding a new partner for TroVax might not prove as difficult as it might have been, thanks to the recent success of another cancer vaccine, Dendreon’s Provenge. Shares of Oxford BioMedica closed up 16 percent Wednesday, on the London exchange.
H1N1 Swine Flu Spreads to 10 States, 91 Americans Infected
Federal health officials, led by newly confirmed HHS Secretary Kathleen Sebelius in her first press conference as health chief, said this morning that the laboratory-confirmed cases of the 2009 H1N1 influenza virus has risen to 91 in the U.S., infecting Americans in 10 states. CDC Acting Director Richard Besser, who confirmed the first U.S. death from the virus in a 23-month-old child in Texas, said work is under way to develop a vaccine. Meanwhile, Homeland Security Secretary Janet Napolitano was on Capitol Hill describing measures the administration is taking to keep the virus contained.
Alnylam to Pay up to $31M to License Isis’ Single-Stranded RNAi Technology
Two leaders in RNAi drug development - Isis Pharmaceuticals Inc. and Alnylam Pharmaceuticals Inc. - have formed an alliance to develop single-stranded RNAi technology in a deal worth up to $31 million. Alnylam, which will fund the research activities at a minimum of $3 million a year for three years, has focused on traditional RNAi technology using double-stranded small interfering RNA (siRNA). But Isis’s chemically modified, single-stranded RNA technology could result in drugs that have better properties and are better tolerated, and are easier and cheaper to make, Stanley Crooke, chairman and CEO of Isis, told BioWorld Today.
New Delivery Technology Plus New Target Equals New Drug Class
Researchers have combined a new delivery technology with a new target to debut what could help further the development of a new class of oral anti-inflammatory drugs down the road. First they used a yeast-derived oligosaccharide to make a delivery shell, which is filled with short interfering RNA that targets a kinase that appears to control production of the inflammatory cytokines via a previously unrecognized pathway. Using their combination they were able to knock down the production of TNF-alpha and interleukin-1b by macrophages in response to inflammatory stimuli.
Genaera Calling it Quits
Genaera Corp., which has twice restructured in the past year to conserve cash, has decided to fold its tent and liquidate. The firm will focus on finding buyers for its pipeline products.
Also in the News:
Active Biotech, AEterna Zentaris, Antigenics, Applied Biosystems, Applied Protein Sciences, Basilea, Bayer Healthcare, Bial-Portela, Biogen, Biomodels, Boehringer, Ceragenix, Clinical Genomics, CombiMatrix, Cougar Biotechnology, DeCode, Eisai, GeneNews, Genta, Geospiza, Kinaxo, MAST BioSurgery, Novavax, Pharmalink, Qiagen, Stallergenes, Teva, United Therapeutics, Vitrology
EASL Roundup: Anadys, Salix, Schering
In the flurry of EASL news breaking today, shares of Anadys Pharmaceuticals Inc. plunged 42 percent in midday trading amid safety concerns about polymerase inhibitor ANA598. Meanwhile, Schering-Plough Corp. released final data from a Phase II trial of protease inhibitor boceprevir in treatment-naïve HCV patients. And Salix Pharmaceuticals Ltd. said the antibiotic rifaximin provided significant protection against hepatic encephalopathy breakthrough episodes in a Phase III trial.
NitroMed, on Verge of Merger, Sells Technology to NicOx for $7.8M
NitroMed Inc. agreed to sell and license certain patents and patent applications associated with its nitric oxide-based technology platform to NicOx SA in exchange for €6 million (US$7.8 million), including €2 million at signature and a further €4 million upon NicOx fulfilling certain future business criteria. NicOx is not acquiring any rights to BiDil (isosorbide dinitrate/hydralazine hydrochloride), the heart drug targeted specifically to black patients. NitroMed’s merger agreement with Deerfield Management recently was approved by NitroMed shareholders and is expected to close “as soon as practicable,” the company said.
Cattle Genome Studies Could Advance Biomedical Research
As researchers published two genome studies of the domestic cattle, Bos Taurus, in Science, the natural assumption is that their most direct applications of the study are in livestock biology. But Harris Lewin, author of a Perspectives piece that accompanies the papers, said in a podcast published to the Science website that the findings most likely will bring advances in biomedical research as well, because cows appear to be resistant to several types of diseases that plague humans. “Cattle rarely develop spontaneous cancers,” he said. Likewise, “I don’t know of a single example of an autoimmune disease in cattle.”
FDA Won’t Fight Ruling on Nonprescription Plan B for 17-Year-Olds
The FDA late Wednesday said it would comply with a judge’s order to permit the emergency contraceptive Plan B to be sold to women as young as 17 without a prescription. In a brief statement, the agency said it would not appeal last month’s order from Federal Judge Edward Korman, who called the FDA’s August 2006 action to restrict over-the-counter sales of Plan B to women 18 years or older a decision that was based on political pressure rather than permissible health and safety concerns.
Acorda’s Quick Turnaround on Fampridine NDA Boosts Shares
Acorda Therapeutics Inc. managed to ease some investor concerns with its quicker-than-expected resubmission of a new drug application for Fampridine-SR, a drug designed to improve walking ability in multiple sclerosis patients, following a refusal to file (RTF) letter. Shares of the Hawthorne, N.Y.-based firm were up 18 percent in morning trading Thursday. Acorda reported receiving the RTF late last month and said the FDA pointed to formatting issues with the electronic filing document and requested pharmacokinetic data from a completed fed/fasted study, plus some additional analytic information.
Also in the News:
Alethia Biotherapeutics, Ascenion, Celera, Celgene, DeCode, Diamyd, HUNT Biosciences, Icagen, Idenix Pharmaceuticals, MedMira, Nuvo Research, Progen, SAFC Biosciences, Sanaria, Targacept, Trion Pharma, Trubion, Vical, Vivalis
Genentech Deal Looking Better; Avastin Misses in First Adjuvant Trial
Though some analysts believed Genentech Inc. could have gotten more than $95 per share for its remaining minority stake in the $46.8 billion deal with Roche Holdings AG earlier this year, the buyout price was looking pretty good Wednesday, after Genentech reported that cancer drug Avastin (bevacizumab) missed its endpoint in an adjuvant colon cancer study. While results of the study are not expected to have any effect on sales of Avastin in its approved metastatic disease indications, analysts and investors had awaited data from the colon cancer study as a signal for the drug’s potential in the $5 billion adjuvant market.
Gilead Surprises Wall Street with Solid Quarter
Shares of Gilead Sciences Inc. gained more than $3, or 7 percent, in morning trading after the Foster City, Calif.-based firm reported a 21 percent increase in first-quarter profits, beating Wall Street’s expectations. The bulk of the firm’s revenue came from sales of its HIV drugs, including Truvada and Atripla. Meanwhile, shares of Genzyme Corp. lost more than $2 after the Cambridge, Mass.-based company’s revenues missed the mark.
Start-up Archer Looks to Move Quickly
Archer Pharmaceuticals Inc. was founded just late last year with the goal of repurposing an existing drug for Alzheimer’s disease, and the company is looking to raise $25 million to move its two lead compounds to clinical trials in the coming months. Partner discussions with big pharmaceutical companies are going “quite nicely,” Archer founder Michael Mullan said.
Link Between Inflammation, Cancer Clarified
The basic link between chronic inflammation and cancer is well known. But most of its details, as well as when immune activation is helpful and when it makes things worse in cancer, are not. Data presented at the AACR this week, as well as a recent paper in Science, provide new insights into these links.
Also in the News:
Abraxis BioScience, AcelRx, AEterna Zentaris, Affymetrix, Amylin, Avila, BioMarin, Calistoga Pharmaceuticals, Capstone Therapeutics, Celator Pharmaceuticals, Cubist Pharmaceuticals, Curis, Cytokinetics, Genzyme, Geron, Immtech, InteRNA Technologies, Lorus Therapeutics, Med BioGene, Medarex, Micromet, Nektar Therapeutics, NovaBay Pharmaceuticals, Onconova Therapeutics, Oxigene, Pharmos, Scynexis, Topica, Tranzyme Pharma
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