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Pharmaceutical companies with a set Phase III data release date very often have a run-up leading into the release date. I usually try to buy the stocks 3-9 months before the catalyst date to make profit from the run-up. I screened for companies that have a Phase III data release date set during the next 3-9 months. I wrote the part I of an article titled "5 Pharmaceutical Companies With Phase III Clinical Study Catalysts During The Next 3-9 Months" on August 20. Here is a look at 5 additional companies that I found.

1. The Medicines Company (MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

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Upcoming Phase III catalysts

From the most recent 10-Q filing:

As of July 25, 2012, we had enrolled approximately 750 patients in the SOLO I clinical trial and approximately 450 patients in the SOLO II clinical trial. If we complete patient enrollment on the expected timeline, we expect that we will have the results from the SOLO I trial by the end of 2012. If the SOLO I trial results are positive, we plan to accelerate enrollment in the SOLO II trial. Under the accelerated timeline, if the results of the trials warrant, we would expect to file an NDA in the middle of 2013.

Oritavancin is an innovative, investigational hospital-based antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria including staphylococcal strains with resistance to methicillin (MRSA) and vancomycin.

Financials

The company reported the second-quarter financial results on July 25 with the following highlights:

Revenue$135.7 million
Net income$13.8 million
Cash$517.5 million

Outlook

2012 financial goals:

  • Net revenue 9‐11% growth in 2012 over 2011
  • Cost of revenue 33‐34% of net revenue
  • R&D 20% of net revenue
  • SG&A flat to up slightly compared to '11
  • Income from operations to grow faster than revenues
  • Tax provision income statement tax provision 38‐40%
  • Tax (CASH) minimal cash taxes in 2012

My analysis

The stock has a $34 price target from the Point and Figure chart. I believe the stock could challenge the $30 level after positive results from the SOLO I trial by the end of 2012. The stock has seen some insider selling in June - August 2012 time frame.

2. Nektar Therapeutics (NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca (AZN) for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic in development to treat chronic pain, is in Phase 2 development in chronic pain patients. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study for the treatment of metastatic breast cancer and in Phase 2 studies for the treatment of ovarian and colorectal cancers.

Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including Affymax's (AFFY) OMONTYS for anemia, UCB's Cimzia for Crohn's disease and rheumatoid arthritis, Roche's (RHHBY.PK) PEGASYS for hepatitis C and Amgen's (AMGN) Neulasta for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's (BAX) BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 1 clinical development.

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Upcoming Phase III catalysts

Howard W. Robin, President and Chief Executive Officer of Nektar commented on August 9:

"The Phase 3 program for naloxegol is on track and AstraZeneca and Nektar plan to announce high-level results from the pivotal efficacy studies in the fourth quarter of 2012. NKTR-181 received Fast-Track designation from the FDA reflecting the important medical need addressed by this new opioid molecule."

NKTR-181 is a mu-opioid analgesic investigational drug candidate with a novel molecular structure designed to provide potent pain relief while reducing the serious side effects of respiratory depression, sedation and abuse potential associated with conventional opioids.

Financials

The company reported the second-quarter financial results on August 9 with the following highlights:

Revenue$23.7 million
Net loss$34.3 million
Cash$477.1 million

This cash balance does not include the proceeds from the $125.0 million issuance of Senior Secured Notes that closed on July 11, 2012.

My analysis

The stock has a $17.25 price target from the Point and Figure chart. The stock did see one insider sell in July 2012. I believe the stock could challenge the $10 mark after positive Phase III data in the fourth quarter.

3. Omeros (OMER) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system. The company's most clinically advanced potential products are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, bleeding and central nervous system disorders.

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Upcoming Phase III catalysts

On August 8 Omeros reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. OMS103HP is a proprietary drug product added to standard irrigation solutions and delivered to the operative site throughout arthroscopy to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to improve postoperative functional outcomes.

The Phase 3 clinical program for OMS103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. The primary endpoint for both trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in Omeros' earlier successful Phase 2 meniscectomy trial.

The last patient enrolled in this Phase 3 clinical trial has undergone surgery and is now participating in the study protocol's postoperative evaluations. Omeros expects to be able to announce data from this trial during the second half of 2012 after those evaluations are complete. Assuming positive data from the current trial, Omeros plans to initiate enrollment in its second Phase 3 meniscectomy trial following discussions with European regulatory authorities.

Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros commented:

"With this enrollment milestone achieved, we expect to announce data from three of our clinical programs during the remainder of 2012. In addition to wrapping up our Phase 3 OMS103HP trial, our other Phase 3 clinical program - OMS302 for lens replacement surgery - will complete its Phase 3 trial and, if the outcome is positive, we plan to submit both US and EU marketing applications in the first part of 2013. The Phase 1 clinical trial of our PDE10 inhibitor for cognitive disorders also remains on track for 2012 data, and we expect that one or more of our other pipeline programs will advance into the clinic next year."

Financials

The company reported the second-quarter financial results on August 7 with the following highlights:

Revenue$1.5 million
Net loss$8.5 million
Cash$7.3 million

On July 2, 2012, Omeros completed a public offering pursuant to which it sold 3,365,854 shares of its common stock at a price of $10.25 per share for estimated net proceeds of $32.4 million.

My analysis

The stock did see one insider buy in June 2012. I believe we could see $15 share price after positive Phase III data later this year. I am expecting the 200 day moving average at $8 level currently to act like a support for the stock going into the data release.

4. XenoPort (XNPT) is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant is approved in the United States for the treatment of RLS in adults and for the management of PHN in adults. GSK holds commercialization rights and certain development rights for Horizant in the United States. Regnite is approved for the treatment of RLS in adults in Japan. Astellas holds all development and commercialization rights for Regnite in Japan and five other Asian countries. XenoPort holds all other world-wide rights and has co-promotion and certain development rights to gabapentin enacarbil in the United States. XenoPort's pipeline of product candidates includes potential treatments for patients with spasticity, Parkinson's disease and relapsing-remitting multiple sclerosis.

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Upcoming Phase III catalysts

William Harris, CFO, commented on August 14:

"Our most advanced product candidate arbaclofen placarbil is currently in a phase III trial in MS patients with spasticity, we expect top line results from this study in the first quarter of next year and assuming a positive outcome we expect to file an NDA under 505(b)(2) in the second half of next year."

Arbaclofen placarbil (AP) is a patented new chemical entity that utilizes naturally-occurring, high-capacity nutrient transporters in the gastrointestinal tract to generate active, efficient absorption into the body. Once absorbed, AP is rapidly converted to the R-isomer of baclofen, a generic drug that is racemic (a mixture of the R- and S-isomer). Baclofen is a selective GABA-B agonist. XenoPort currently holds all rights to this product candidate.

Financials

The company reported the second-quarter financial results on August 7 with the following highlights:

Revenue$10.4 million
Net loss$8.0 million
Cash$81.7 million

Upcoming (other) milestones

The company gave the following update on its upcoming milestones on August 14:

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My analysis

The stock has a $19.25 price target from the Point and Figure chart. I believe we could reach $12-$15 in Q1-2013 if the Phase III results are positive and $20 sometime in 2014 after approval. The stock did see some insider buying on August 9.

5. Anacor (ANAC) is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered seven compounds that are currently in development. Its two lead product candidates are topically administered dermatologic compounds - tavaborole, a topical antifungal for the treatment of onychomycosis and AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of atopic dermatitis and psoriasis. In addition to its two lead programs, Anacor has discovered two other clinical product candidates, AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively. The company has also discovered three compounds that it has out-licensed for further development - GSK '052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which is licensed to GlaxoSmithKline (GSK); AN8194, which is licensed to Eli Lilly and company (LLY) for an animal health indication; and AN5568, which is licensed to the Drugs for Neglected Diseases initiative for sleeping sickness. In addition, Anacor has a research and development agreement with Medicis Pharmaceuticals (MRX) to discover and develop boron-based small molecule compounds directed against a target for the potential treatment of acne.

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Upcoming Phase III catalysts

David Perry, CEO of Anacor Pharmaceuticals commented on August 9:

"Our Phase 3 trials of tavaborole in onychomycosis are progressing well, and we expect to announce top-line results from the first of these trials in January 2013 and from the second trial approximately six weeks later."

Onychomycosis is primarily caused by dermatophytes, which are fungi that infect the skin, hair or nails. The infection involves the nail plate, the nail bed and, in some cases, the skin surrounding the nail plate. Onychomycosis causes nails to deform, discolor, thicken, become brittle and split and separate from the nail bed. Toenails affected by onychomycosis can become so thick that routine trimming of the nails becomes difficult. The condition can also cause pain while individuals wear shoes, leading to difficulties walking. Onychomycosis can also lead to social embarrassment due to the unsightly appearance of the infected nails and because it may be perceived to be an active infection and contagious.

Financials

The company reported the second-quarter financial results on August 7 with the following highlights:

Revenue$2.6 million
Net loss$14.8 million
Cash$41.0 million

The company projects cash, cash equivalents and short-term investments to be at least $25 million at year-end 2012, which the company believes will be sufficient to meet its anticipated operating requirements until top-line data from two Phase 3 trials of tavaborole in onychomycosis.

Upcoming (other) milestones

Tavaborole in onychomycosis

  • The company expects to announce top-line data from the first Phase 3 trial of tavaborole in January 2013 and from the second Phase 3 trial approximately six weeks later.
  • The company expects to file a New Drug Application, or NDA, for tavaborole in the first half of 2013.

AN2728 in atopic dermatitis

  • The company expects data from the Phase 2 safety, PK and efficacy study in adolescents near the end of 2012 and the Phase 2 dose-ranging study in adolescents in early 2013.
  • The company expects to initiate a Phase 2 safety, PK and efficacy study in children (ages 2 to 11) shortly after completing the Phase 2 safety, PK and efficacy study in adolescents.
  • The company expects to initiate a Phase 3 trial in atopic dermatitis in mid-2013, subject to the results of Phase 2 studies.

GSK '052

  • The company expects to announce an update on GSK '052 development plans later this year.

My analysis

The stock has seen steady insider selling since May 2011. I would expect a price range of $8-$10 after positive Phase III results in January 2012. If the results are negative we would most likely dip below $4.

Source: 5 Pharmaceutical Companies With Phase III Clinical Study Catalysts During The Next 3 - 9 Months (Part II)