New entity has one product, a fentanyl sublingual spray, that has completed Phase III trials.

NeoPharm, based in Lake Bluff, IL, has completed its merger with Insys Therapeutics, a pharmaceutical company located in Phoenix, AZ. In addition, NeoPharm intends to change the name of the combined entity to Insys Therapeutics. Additionally, the Insys board of directors and management team have replaced those of NeoPharm.

The combined company has a pipeline focused on pain and oncology. Initial efforts will concentrate on moving NeoPharm’s LEP-ETU into Phase III trials in metastatic breast cancer. The firm will at the same time work on its NDA submission for fentanyl sublingual spray, which is an Insys product. The product finished a Phase III randomized, double-blind, placebo-controlled multicenter study as a treatment of breakthrough cancer pain in February.

“We plan to file our NDA in the coming months for our sublingual fentanyl spray, which has demonstrated onset of action in five minutes, far superior to currently marketed products for breakthrough cancer pain,” says president Michael Babich. “The U.S. market for this product is a half billion dollar opportunity, and the product’s ease of use will be welcomed by both doctors and patients who suffer from breakthrough cancer pain.”

NeoPharm entered into the merger agreement with Insys Therapeutics on October 29. Under the terms of the agreement, NeoPharm was to issue approximately 19.5 million shares of common stock and 14.9 million shares of a newly created convertible preferred stock.

The NeoPharm board also approved the distribution, immediately after the merger, of nontransferable contingent payment rights to its stockholders of record as of November 5. These rights will entitle the premerger stockholders to receive cash payments aggregating $20 million if, prior to the five year anniversary of the merger, the FDA approves an NDA for at least one of NeoPharm’s current drugs.

Insys’ focus has been on applying new and proprietary formulations and delivery methods to existing pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery, and increased patient compliance.

NeoPharm has built its drug development program around two technologies: a NeoLipid® liposomal drug delivery system and a tumor-targeting toxin platform, which includes development in pulmonary fibrosis.

The NeoLipid technology enables the entrapment of difficult-to-deliver drugs in small, homogenous, and stable liposomes, according to NeoPharm. It utilizes easy-to-use (ETU) reconstitutions of lyophilized (or freeze-dried) products with the goal of creating an extraordinarily stable liposomal product.

LEP-ETU is NeoPharm’s NeoLipid liposomal formulation of the widely used cancer drug paclitaxel. Bristol-Myers Squibb’s paclitaxel, also known as Taxol, is approved in the U.S. for the treatment of ovarian, breast, and lung cancers. Paclitaxel cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor®) and ethanol, which can lead to significant side effects such as hypersensitivity reactions and cardiac toxicities. NeoPharm hopes to show that its NeoLipid technology, which eliminates the need for Cremophor and ethanol, permits delivery of paclitaxel treatment with fewer side effects.

Besides LEP-ETU, NeoPharm has two more products in clinical development: LEP-DT is in Phase II development for metastatic solid tumors, and cintredekin besudotox is in Phase I for untreatable brain diseases. LEP-DT is a NeoLipid formulation of the anticancer agent docetaxel, which is the active ingredient in sanofi-aventis’ Taxotere, sanctioned for use in certain breast cancers, non-small-cell lung cancer, gastric adenocarcinoma, head and neck cancer, and prostate cancer.

Cintredekin besudotox was developed on NeoPharm’s tumor-targeting platform. This recombinant protein consists of two parts: a tumor-targeting molecule (IL13) and a cytotoxic agent (PE38). IL13 receptors are found on malignant glioma cells but not to any measurable degree, if at all, on healthy brain cells, the company points out.

Cintredekin besudotox is also in preclinical investigations as a treatment for idiopathic pulmonary fibrosis. LE-rafAON, another NeoLipid product, rounds up the preclinical pipeline and is being tested against pancreatic cancer. LE-rafAON is a formulation of the antisense oligonucleotide agent, c-raf. 

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