ALTU-135 consists of three active ingredients designed to improve fat, protein, and carbohydrate absorption in individuals with pancreatic insufficiency. The drug replaces missing digestive enzymes and has been granted orphan drug status and fast-track designation by the FDA. It allows for more convenient one-capsule dosing with meals and snacks and is synthesized in a highly purified, non-animal-origin process. Altus expects to initiate phase 3 trials this quarter.
According to IMS Health 2005, worldwide sales of pancreatic enzymes were more than $707 million, with approximately $190 million in North America alone. This drug is an improvement over currently marketed pancreatic enzyme replacements, which have inconvenient dosing regimens that involve taking multiple capsules with each meal, as well as manufacturing issues related to their animal origins. In fact, the FDA is requiring all existing and newly proposed pancreatic enzymes to undergo evaluation through new drug applications.
ALTU-238 is a crystalline formulation of human growth hormone (hGH) designed for once-weekly administration using a fine-gauge needle -- an important factor in patient comfort, and therefore compliance -- for the treatment of hGH deficiencies in both pediatric and adult populations. Altus partnered with Genentech
Given the potential of these two compounds, Altus is an interesting opportunity for biotech investors. Shares could also benefit if Genentech chooses to exercise its global marketing option for ALTU-238. Given its strong balance sheet and low-risk approach of improving on existing drug therapies, Altus is poised to climb to new heights from current levels.
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.