Washington Editor

Cyclacel Pharmaceuticals Inc. has acquired Cary, N.C.-based Align Pharmaceuticals LLC in a deal worth up to $3.8 million in cash.

The deal also involves an undisclosed amount of stock paid to Align Holding LLC, which is changing its name, upon the achievement of certain operational and financial milestones, said Spiro Rombotis, CEO and president of Berkeley Heights, N.J.-based Cyclacel. However, Cyclacel will not be required to issue more than 258,840 shares, the firm said.

The acquisition brings to Cyclacel, which develops products for hematological and solid tumor cancers, three prescription drugs used to manage the effects of radiation and chemotherapy in cancer patients.

Align's Xclair Cream, which contains hyaluronic acid, is indicated for dermatitis caused by radiation therapy in cancer patients. The firm's Numoisyn Liquid and Numoisyn Lozenges are used to treat xerostomia, or dry mouth, resulting from oncology therapy or other causes.

Align holds the exclusive North American rights to Xclair and Numoisyn from Godalming, UK-based Sinclair Pharma plc.

Cyclacel plans to move Align's operations to its Berkeley Heights, N.J., site, Rombotis told BioWorld Today.

Align's current CEO, William C. Collins, will become general manager of the new subsidiary, which will retain the Align name.

Rombotis emphasized that the Align acquisition brings an "evolutionary change" to Cyclacel and is not a "revolutionary change" for the firm.

"We are not changing our model" of developing novel cancer therapies, he insisted.

Because the Align deal is one that is "self-funding," Rombotis explained, it allows Cyclacel to continue to focus on its clinical development activities for its three main investigational products and not be distracted by the sales and marketing of the new products the firm has acquired.

"Align, which is modest in scale, won't endanger the finances of Cyclacel," he maintained. "It's an opportunity for us to build a resource and yet not distract from delivering what is our main mission."

The acquisition, Rombotis said, will increase the firm's "negotiating leverage" in potential partnering deals for its investigational products, particularly sapacitabine (CYC682), which he said, "was foremost in our minds" when the company sought the agreement with Align.

"The purpose or timing of the Align deal is to leverage our hand with regard to how we might exploit sapacitabine commercially," Rombotis said.

In Phase I studies, he said, sapacitabine, an orally-available, cell cycle-modulating nucleoside analogue, showed "dramatic" activity in patients with leukemia and "encouraging" activity in patients with solid tumors.

The company has initiated a Phase II trial of sapacitabine in patients with cutaneous T-cell lymphoma, he noted.

Cyclacel also plans to soon announce a second Phase II trial of the compound in patients with "another cancer in the hematology family," Rombotis added. In addition, Cyclacel plans to study sapacitabine in 2008 in patients with non-small-cell lung cancer, he said.

The firm's other investigational products include seliciclib (CYC202), an orally-available cyclin-dependent kinase inhibitor, and CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor.

Seliciclib currently is being studied in Phase II clinical development for the treatment of lung cancer and also is being evaluated for nasopharyngeal cancer.

CYC116 is in Phase I clinical development in patients with solid tumors.