A company developing through-the-skin medications for people who cannot, should not or will not swallow tablets and capsules, reported today that its technology is being recognized as a potential solution to industry drug-development challenges faced by many of the 7,500 formulation and manufacturing experts attending the American Association of Pharmaceutical Scientists meeting here.
“These executives are interested in exploring the possibilities of our absorption-enhancing technology, known as SEPA(R) (Soft Enhancement of Percutaneous Absorption).”
“Our technology may enable pharmaceutical companies to reformulate drugs presently administered as tablets or capsules, or even injected, so they can be delivered through the skin as gels, creams or other topical forms” Mr. Snyder said.
Since 1997, MacroChem has sought and received U.S. and foreign patent protection on SEPA-containing topical formulations of off-patent drugs such as minoxidil, a family of hormones, a group of non-steroidal anti-inflammatory drugs, anti-fungal agents and alprostadil, the active ingredient in its Topiglan(R) product.
According to Mr. Snyder, Topiglan demonstrates how pharmaceutical companies can apply MacroChem’s absorption-enhancement technology to create valued, patentable products.
“Our Phase 3 topical for erectile dysfunction, Topiglan(R), is being recognized as the virtual ‘poster child’ for life cycle management,” Mr. Snyder said, “because it addresses all the objectives the industry is trying to meet: New patent-protected products created less expensively out of old ones … drugs capable of meeting the needs of industrial society’s aging consumers … drugs that don’t interfere with the many medicines these individuals are already consuming … drugs with potential sales of $1 billion or more.”
Topiglan combines alprostadil — a synthetic version of a blood-vessel dilator discovered in the 1930’s and found in human semen — with SEPA, MacroChem’s patented excipient that enables through-the-skin absorption of many drug molecules. Alprostadil has key advantages over most oral drugs marketed and being developed for male impotence, because it acts on the penis, doesn’t appear to interact with any drugs likely male patients are taking, and, due to its metabolic profile, is not likely to pose a challenge to their aging hearts.
“Unlike the active ingredient in oral drugs to treat erectile dysfunction, alprostadil cannot be taken by mouth, and has not been shown in clinical trials to induce intercourse-capable erection in impotent men when applied alone directly to the penis. Currently, it must be injected into the shaft of the penis, or inserted into the urethra as a suppository — considered too uncomfortable by most men.” Mr. Snyder said.
A Topiglan user is expected to apply a small (0.25ml) fingertip of gel to the head of his penis about 15 -60 minutes before attempting intercourse, as SEPA takes alprostadil through penile skin.
“Topiglan shows how MacroChem can add SEPA to an off-patent drug with known pharmacology but limited by route of administration or systemic side effects, and formulate it into a patent-protected new product with great appeal to patients and physicians,” Mr. Snyder said.
MacroChem is a drug development company specializing in transdermal (through-the-skin) drugs with sales potentials of hundreds of millions to $1 billion or more, based on its platform absorption-enhancer, SEPA(R). MacroChem expects to complete its current Topiglan phase 3 trial and other requirements for submitting an NDA for Topiglan in late 2002. While engaged in these trials, MacroChem is simultaneously supporting the due-diligence evaluations of several major multinational drug companies interested in licensing Topiglan and its through-the-nail treatment for nail fungus, EcoNail(TM). Other SEPA-enhanced products in the MacroChem development portfolio address other major-market indications, including localized pain and hormone deficiency.
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