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Pharmaceutical companies very often have a run-up leading into drug approval dates. I usually try to buy the stocks three to nine months before the anticipated catalyst date to make profit from the run-up. I screened for companies that have an European Medicines Agency [EMA] decision date set for the next 3-12 months. These dates are only estimates by the respective companies and could still change. More information how this approval process works can be found from this article. I am only recommending these companies for run-up candidates not for long term investments. I wrote the part I of an article titled "5 Pharmaceutical Companies With EMA Catalysts During The Next 3 - 12 Months" on August 31. Here is a look at five additional companies that I found.

1. Aegerion Pharmaceuticals (AEGR) is an emerging biopharmaceutical company focused on the development and commercialization of novel, life-altering therapeutics to treat debilitating and often fatal rare diseases. Aegerion is motivated by its commitment to patients first.

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Upcoming EMA catalyst

Aegerion's New Drug Application (NDA) for its product, lomitapide, is under review by the U.S. Food and Drug Administration [FDA] and its Marketing Authorization Application [MAA] for lomitapide is under review by the European Medicines Agency. Aegerion is seeking approval of lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in adult patients with Homozygous Familial Hypercholesterolemia (HoFH).

Financials

The company reported the second-quarter financial results on August 8 with the following highlights:

Revenue$0
Net loss$13.9 million
Cash$100.6 million

Outlook

The company is expecting cash burn of $43M - $48M for the full-year 2012.

Cash Flow Guidance:

  • Achievement of positive cash flow expected in 2014; assuming first cycle FDA approval in late 2012 and EMA approval in first half 2013

News

Aegerion announced on August 14 that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on October 17, 2012, to review the company's New Drug Application for lomitapide in the treatment of adult patients with Homozygous Familial Hypercholesterolemia (HoFH).

My analysis

The stock has seen some insider buying in March 2012. There has also been quite heavy insider selling in the beginning of 2012. Aegerion is expecting EMA approval in the first half of 2013. The first catalyst for the stock is the FDA Advisory Committee meeting in October 17. If the panel votes for approval I believe the stock could challenge $20. If there is a negative vote the stock would likely dip below $10.

2. Medivation (MDVN) is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families.

Upcoming EMA catalyst

Medivation and Astellas Pharma (TSE: 4503) announced on June 26 that Astellas has submitted a Marketing Authorisation Application to the European Medicines Agency for enzalutamide (formerly MDV3100) for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Financials

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

Revenue$42.9 million
Net loss$5.5 million
Cash$344.5 million

Outlook

Medivation expects total operating expenses for 2012, net of cost-sharing payments from Astellas, to be between $183 and $198 million, approximately $25 million of which consists of non-cash stock-based compensation expense. Medivation continues to expect to incur approximately $15 million in capital expenditures in 2012, primarily related to leasehold improvements at its new corporate and commercial headquarters facilities.

News

Medivation and Astellas Pharma (TSE: 4503) announced on August 31 that the U.S. Food and Drug Administration [FDA] has granted approval to Xtand (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Xtandi is an oral, once-daily androgen receptor inhibitor.

My analysis

The stock has a $125 price target from the Point and Figure chart. The stock has seen steady insider selling this year. The last insider buy transaction was in November 2011. I believe the $125 price target is achievable even before the EMA approval of enzalutamide some time next year based on the MAA submission date.

3. Ligand (LGND) is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure. Ligand's goal is to produce a bottom line that supports a sustainably profitable business. By diversifying the portfolio of assets across numerous technology types, therapeutic areas, drug targets, and industry partners, the company offers investors an opportunity to invest in the increasingly complicated and unpredictable pharmaceutical industry. In comparison to its peers, the company believes Ligand has assembled one of the largest and most diversified asset portfolios in the industry with the potential to generate revenue in the future. These therapies address the unmet medical needs of patients for a broad spectrum of diseases including diabetes, hepatitis, muscle wasting, thrombocytopenia, dyslipidemia, anemia, multiplemyeloma and osteoporosis. Ligand's Captisol platform technology is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline (GSK), Merck (MRK), Pfizer (PFE), Eli Lilly & Company (LLY), Baxter International (BAX), Bristol-Myers Squibb (BMY), Celgene (CELG), OnyxPharmaceuticals (ONXX), Lundbeck Inc., The Medicines Company (MDCO), Curis (CRIS) and Rib-X Pharmaceuticals (RIBX).

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Upcoming EMA catalysts

1. Ligand's partner Pfizer announced on July 19 that the European Medicines Agency accepted for review the Marketing Authorization Application for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for post menopausal women with auterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture. Pfizer expects a decision from the European Commission in 2013.

2. Ligand's partner GlaxoSmithKline announced on May 30 that it has submitted regulatory applications in the United States and European Union related to eltrombopag (Promacta/Revolade) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia), specifically:

  • A supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimize interferon-based therapy.
  • A variation to the Marketing Authorization Application to the European Medicines Agency for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy.

Financials

The company reported the second-quarter financial results on August 8 with the following highlights:

Revenue$5.7 million
Net loss$2.3 million
Cash$10.4 million

Outlook

Ligand expects 2012 total revenues to be approximately $30 million, with revenue in the third quarter of approximately $8 million and revenue in the fourth quarter of approximately $11 million. Revenue for the second half of the year may fluctuate significantly between the third and fourth quarter based on the timing of license payments and customer purchases of Captisol. The company expects combined research and development and general and administrative expenses of approximately $25 million during 2012, including approximately $6 million of non-cash expense items. Additionally, the company expects its operations to be profitable and cash-flow positive for the year.

My analysis

The stock has a $35 price target from the Point and Figure chart. The stock has seen more insider buying than selling since May 2010. The last insider buy was in August 2012. The company expects its operations to be profitable and cash flow positive for the year. The EMA approval of bazedoxifene/conjugated estrogens (BZA/CE) is expected in 2013 according to Ligand. I believe the stock could trade in a range of $20-$25 after the EMA approval of BZA/CE. If BZA/CE fails to gain EMA approval the stock would likely dip below $15.

4. Ariad Pharmaceuticals (ARIA) is an emerging global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. Ariad's approach to structure-based drug design has led to several internally discovered, molecularly targeted product candidates for drug-resistant or difficult-to-treat cancers, including chronic myeloid leukemia and certain forms of non-small cell lung cancer.

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Upcoming EMA catalyst

Ariad announced on August 30 the submission of a Marketing Authorization Application for its investigational BCR-ABL inhibitor, ponatinib, to the European Medicines Agency. Ariad is seeking marketing approval in the European Union of ponatinib in adult patients with resistant or intolerant chronic myeloid leukemia [CML] and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Committee for Medicinal Products for Human Use [CHMP] has granted Ariad's request for accelerated assessment of the MAA.

Financials

The company reported the second-quarter financial results on August 2 with the following highlights:

Revenue$0.3 million
Net loss$51.3 million
Cash$250.3 million

Outlook

Ariad expects cash used in operations for 2012 to be in the range of $162 million to $167 million. Ariad expects cash, cash equivalents and marketable securities at December 31, 2012 to be in the range of $142 million to $147 million. Ariad estimates that current cash, cash equivalents and marketable securities are sufficient to fund operations to the fourth quarter of 2013.

Other key milestones

A New Drug Application [NDA] is under review by the U.S. Food and Drug Administration [FDA] for U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Ariad's NDA is a rolling submission that includes all sections of the application and will be completed by the addition of a small subset of routine chemistry, manufacturing, and controls [CMC] data that will be submitted later in the third quarter. The FDA has communicated to Ariad that it intends to begin immediate, comprehensive review of the NDA based on the rolling submission. Ariad is seeking accelerated approval of ponatinib and has requested a priority review of the application. The company anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013.

My analysis

The stock has met its $20.5 price target from the Point and Figure chart. The stock has seen steady insider selling since March 2012. There has not been any insider buying since at least March 2012. The company is expecting both the U.S. and the European launch of ponatinib in 2013. If the company is successful in gaining approvals both in the U.S. and Europe. I believe we could see the stock trading in the range of $25-$35. If ponatinib fails to get approved either in the U.S. or Europe we could see the stock below $15.

5. Theravance (THRX) is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system [CNS]/pain. Theravance's key programs include: Relvar or Breo (FF/VI), umeclidinium bromide/vilanterol (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need.

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Upcoming EMA catalyst

GlaxoSmithKline and Theravance announced on July 13 the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.

European Submission:

A Marketing Authorisation Application for FF/VI, with the proposed brand name Relvar, administered by a new dry powder inhaler called Ellipta, has been submitted to the European Medicines Agency for the following indications:

  • Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.
  • COPD (100/25mcg): The symptomatic treatment of patients with COPD with a FEV1 < 70% predicted normal (post-bronchodilator) in patients with an exacerbation history.

US Submission:

A New Drug Application [NDA] for FF/VI, with the proposed brand name Breo, administered by the Ellipta inhaler, has been submitted to the US Food and Drug Administration [FDA], for the following indication:

  • COPD (100/25mcg): The long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations.
  • For asthma, GSK and Theravance are reviewing the strategy for a future US filing.

Financials

The company announced the second-quarter financial results on July 31 with the following highlights:

Revenue$1.4 million
Net loss$37.1 million
Cash$379 million

My analysis

The stock has met its $27 price target from the Point and Figure chart. Glaxosmithkline has been the only insider buying the shares since February 2011. The stock has seen steady insider selling by other insiders since February 2011. The stock could reach a $35 - $40 range after Fluticasone Furoate/Vilanterol (FF/VI), for COPD in the EU and the US, and for asthma in the EU, has received the regulatory approvals. If FF/VI fails to gain these approvals the stock could dip below $20. I am not expecting these regulatory approvals before mid-2013.

Source: 5 Pharmaceutical Companies With EMA Catalysts During The Next 3 - 12 Months - Part II