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Today’s Top Biotech Stories: Albany Molecular Research, Rockwell Medical, and Celgene

By Leo Sun – Mar 24, 2014 at 9:15AM

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Albany Molecular Research, Rockwell Medical, and Celgene could all make health care headlines this morning. Here’s why.

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

Let's take a look at three stocks -- Albany Molecular Research (AMRI), Rockwell Medical (RMTI 5.62%), and Celgene (CELG) -- which could all loom large in health care headlines this morning.

Albany Molecular Research acquires Cedarburg Pharmaceuticals
Albany Molecular Research (also known as AMRI Global) just announced plans to acquire privately held Cedarburg Pharmaceuticals for $38.2 million in cash and the assumption of $2.8 million in liabilities.

Albany Molecular Research's business consists of two primary segments -- Large Scale Manufacturing (LSM) and Discovery, Drug Development, and Small Scale Manufacturing (DDS) -- which provide discovery, development, and manufacturing services for pharmaceutical companies. Cedarburg specializes in developing and manufacturing active pharmaceutical ingredients (APIs) for generic and branded pharmaceutical companies. Cedarburg and Albany Molecular Research had already been longtime partners prior to the deal.

Albany Molecular Research's purchase price of Cedarburg indicates a premium of approximately two times Cedarburg's 2014 revenue and 7 times its adjusted EBITDA from the midpoint of its forward estimates. The deal is expected to close in April 2014, adding $13 million to $14 million to Albany Molecular Research's fiscal 2014 revenue, with full year run-rate synergies of approximately $1.5 million in EBITDA within 12 months of the deal closing.

The deal is expected to be accretive to Albany Molecular Research's full-year earnings, adding between $0.06 to $0.07 per share to its full-year adjusted diluted EPS. This could be a positive development for Albany Molecular Research, which plunged last Friday after being downgraded from neutral to underperform by Sterne Agee, which noted that the stock might have gotten ahead of itself after an impressive 84% rally over the past 12 months.

Rockwell Medical submits an NDA for Triferic
Meanwhile, Rockwell Medical just submitted its NDA (new drug application) to the FDA for Triferic, its late-stage iron replacement drug for iron deficiency in chronic kidney disease (CKD) patients receiving hemodialysis. The NDA submission was based on data compiled from its phase 3 study, as well as efficacy and safety data from additional studies.

Triferic is mixed into dialysate, the liquid used for dialysis that Rockwell also manufactures. By delivering iron into the bone marrow, it can substantially decrease the necessary doses of ESAs (Erythropoiesis-Stimulating Agents) which treat anemia, such as Amgen's (AMGN -0.03%) Procrit, Epogen, and Aranesp. All three drugs can cause notable side effects, including an elevated risk of heart attack and a decline in survival rates for cancer patients -- meaning that anything which can reduce the required doses of ESAs could tremendously benefit patients on dialysis.

Rockwell estimates that the size of Triferic's potential market is $600 million. Analysts believe that Triferic could capture a large portion of that market and generate peak sales between $150 million to $250 million -- which would be a big boost for a company which only reported $52.4 million in revenue in fiscal 2013.

Celgene provides an encouraging update for Otezla
Last but not least, Celgene just provided a positive update regarding Otezla (apremilast), its new oral drug for inflammatory disorders such as psoriasis, rheumatoid arthritis, dermatitis, and Crohn's disease. The FDA approved Otezla last Friday for active psoriatic arthritis in adults, making it the first oral treatment ever approved for the indication.

In the update, Celgene announced that Otezla significantly improved the signs and symptoms of plaque psoriasis (including the scalp and nails) when compared to a placebo in its phase 3 ESTEEM 2 trial by the 16th week, which was consistent with the results of its earlier phase 3 ESTEEM 1 trial.

During the fourth quarter of 2013, Celgene submitted an NDA for psoriasis in the U.S., an NDS (new drug submission) for psoriasis in Canada, and a combined psoriatic arthritis/psoriasis market MAA (marketing authorization application) in Europe. If approved for additional inflammatory indications, analysts expect Otezla to generate peak sales between $500 million and $2 billion.

This means that Otezla and Pomalyst, Celgene's promising new drug for multiple myeloma, could eventually offset the importance of Revlimid, the company's blockbuster blood disorder drug which accounted for 66% of its revenue in fiscal 2013.

Leo Sun has no position in any stocks mentioned. The Motley Fool recommends Celgene. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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