Hot Biotech Companies To Buy For 2014

The Food and Drug Administration (FDA) made a groundbreaking policy change last year that is having a large impact on the biotech industry and creating a big opportunity for investors.

To create a faster path to commercialization for potentially life-saving drugs and medicine, the FDA in July introduced a new "breakthrough" status for drugs that show "substantial improvement on existing therapies for clinically significant endpoints."

 

For an industry that is accustomed to a costly 10-year commercialization process, the breakthrough status is a welcome shift. An accelerated channel to commercialization could enable drug companies to shave years and billions of dollars from the cumbersome process.

Hot Biotech Companies To Buy For 2014: Medivation Inc.(MDVN)

Medivation, Inc., a biopharmaceutical company, focuses on the development of small molecule drugs for the treatment of castration-resistant prostate cancer, Alzheimer?s disease, and Huntington disease. The company?s product candidates under clinical development include MDV3100, which is in Phase 3 development for the treatment of castration-resistant prostate cancer; and dimebon, which is in Phase 3 clinical trial for the treatment of Alzheimer?s disease and Huntington disease. It has collaboration agreements with Pfizer Inc. to develop and commercialize dimebon; and Astellas Pharma Inc. to develop and commercialize MDV3100. The company was founded in 2003 and is based in San Francisco, California.

Advisors' Opinion:

• [By Keith Speights]

  Medivation (NASDAQ: MDVN  ) also presents a threat to Provenge. The biotech obtained approval for Xtandi last August. The prostate cancer drug is approved for patients who weren't helped by chemotherapy.

• [By Sean Williams]

  Friday brought equally good news for Medivation (NASDAQ: MDVN  ) and its advanced prostate cancer drug Xtandi, which also received a positive opinion from the EMA's advisory panel. This really shouldn't come as a surprise as Medivation's oral prostate cancer treatment won FDA approval months early in the U.S., and the 4.8 months of extended median survival it delivered compared to the placebo is remarkable for such an advanced stage disease.

• [By Sean Williams]

  A slew of competitors
  We've had two treatments recently approved by the FDA a full three months ahead of their PDUFA date: Medivation (NASDAQ: MDVN  ) and Astella Pharma's Xtandi, and Bayer and Algeta's Xofigo. Xtandi improved median overall survival to 18.4 months, compared with just 13.6 months for the placebo in trials while Xofigo's median overall survival tallied 14 months, compared with 11.2 months for the control arm.

Hot Biotech Companies To Buy For 2014: Savient Pharmaceuticals Inc(SVNT)

Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing KRYSTEXXA, a biologic PEGylated uricase in the United States. The KRYSTEXXA is being developed as a treatment for chronic gout in patients refractory to conventional therapy. The company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. It sells its products directly to drug wholesalers. The company, formerly known as Bio-Technology General Corp. and changed its name to Savient Pharmaceuticals, Inc. in June 2003. Savient Pharmaceuticals, Inc. was founded in 1980 and is headquartered in East Brunswick, New Jersey.

Advisors' Opinion:

• [By James E. Brumley]

  It's still too soon to say Savient Pharmaceuticals Inc. (NASDAQ:SVNT) is off and running. In fact, the stock's decidedly NOT off and running yet. But, it's not too soon to put SVNT on your watchlist of potential breakout candidates, as it's much closer to a breakout than most anyone can see.

• [By James E. Brumley]

  Since 2008's implosion from the stock, the interest in Savient Pharmaceuticals Inc. (NASDAQ:SVNT) has been waning. There was a brief burst of bullishness in September of last year, which stirred the bullish pot a little. But, when SVNT started to fade in October of that year - just as quickly as it had perked up - what lingering hopes there were for the stock finally started to melt away. By the middle of this year, pretty much everyone had written Savient Pharmaceuticals off as a lost cause. Big mistake. Over the last few days, SVNT has almost wiggled its way buck into a bullish zone.

Top Financial Companies For 2014: Scancell Holdings PLC (SCLP.L)

Scancell Holdings PLC is a United Kingdom-based company. The Company�� principal activity of the consists of the discovery and development of monoclonal antibodies and vaccines for the treatment of cancer. In April 2012, the Company completed recruitment to the Phase 1 clinical trial of SCIBI. In May 2012, the Company commenced recruitment and treatment of the first patient in the second part of it Phase 1/2 clinical trial of SCIBI. The Phase 2 part of the trial is conducted in five United Kingdom centers in Nottingham, Manchester, Newcastle, Leeds, and Southampton. On August 15, 2012, the Company announced the development of a platform technology, Moditope.

Hot Biotech Companies To Buy For 2014: Merck & Company Inc.(MRK)

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company?s Pharmaceutical segment provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of bone, respiratory, immunology, dermatology, cardiovascular, diabetes and obesity, infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women's health and endocrine. This segment also offers human health vaccines, such as preventive pediatric, adolescent, and adult vaccines. Its Animal Health segment discovers, develops, manufactures, and markets animal health products. This segment offers antibiotics, anti-inflammatory products, vaccines, products for the treatment of fertility disorders, and parasiticides for cattle, swine, horses, poultry, dogs, cats, salmons, and fish. The Consumer Care segment develops, manufac tures, and markets over-the-counter, foot care, and sun care products. Its over-the-counter product line includes non-drowsy antihistamines; treatment for occasional constipation; decongestant-free cold/flu medicine for people with high blood pressure; nasal decongestant spray; and treatment for frequent heartburn. This segment?s foot care products comprise topical antifungal, and foot and sneaker odor/wetness products; and sun care products include sun care lotions, sprays and dry oils; and sunburn relief products. The company serves drug wholesalers and retailers, hospitals, government agencies, physicians, physician distributors, veterinarians, animal producers, and managed health care providers, as well as food chain and mass merchandiser outlets in the United States and Canada. Merck & Co., Inc. was founded in 1891 and is headquartered in Whitehouse Station, New Jersey.

Advisors' Opinion:

• [By Maxx Chatsko]

  One company that is about to face the brunt of its patent cliff exposure is Merck (NYSE: MRK  ) , which is set to lose exclusivity for its former megablockbuster Singulair in its last major worldwide markets this year. There are still some interesting molecules in the pipeline and several major approvals pending. However, I don't think Merck stock is worth owning. Here are a few reasons why.

• [By Matt Thalman]

  Merck (NYSE: MRK  ) also announced today that it would be buying back additional shares. The company plans to spend $5 billion on almost 100 million shares that Goldman Sachs owns. While 100 million share buyback sounds great, Merck has 3.02 billion shares outstanding so, although this move will reduce float, the company could have spent the money in a wiser way. Merck has been facing a number of headwinds as major drugs fall off patent protection and with $16 billion in cash but slightly more than $20 billion in debt, shareholders would likely have been better off if the company held on to the $5 billion or paid down some of its debt.

• [By Paul Ausick]

  Big Earnings Movers: Petroleo Brasileiro SA (NYSE: PBR) is up 9.1% at $17.35 after reporting earnings and getting a ratings boost. Merck & Co. Inc. (NYSE: MRK) is down 2.5% at $45.39 as the company struggles to boost revenues. Burger King Worldwide Inc. (NYSE: BKW) is up 5.8% at $20.91 as franchise revenues rose much faster than costs. Loews Corp. (NYSE: L) is down 0.2% at $48.70.

Hot Biotech Companies To Buy For 2014: RXi Pharmaceuticals Corp (RXII.PK)

RXi Pharmaceuticals Corporation (RXi), incorporated on September 8, 2011, is a development-stage company. The Company is a biotechnology company focused on discovering, developing and commercializing therapies addressing medical needs using RNA interference (RNAi)-targeted technologies. As of July 12, 2012, RXi was focusing on its internal therapeutic development efforts in fibrosis. RXI-109 is its RNAi product candidate, which is a dermal anti-scarring therapy that targets connective tissue growth factor (CTGF). The Company�� therapeutic platform consists of two main components: RNAi Compounds (rxRNA) and Advanced Delivery Technologies. RNAi compounds include rxRNAori, rxRNAsolo and sd-rxRNA, or self-delivering RNA. On April 26, 2012, it completed the spin-off transaction from Galena Biopharma, Inc. (Galena).

In January 2011, the Company announced research results in collaboration with Generex Biotechnology Corporation, and RXi�� wholly owned subsidia ry Antigen Express, Inc., in developing vaccine formulations for immunotherapy. In January 2011, it announced initial results as part of its collaboration with miRagen Therapeutics, Inc. in creating microRNA mimics, or artificial copies of microRNAs, using the Company�� sd-rxRNA technology. In February 2011, it announced the initiation of RXi�� development program for RXI-109.