Celator's CPX-351 has been granted orphan drug status

Celator announced that the European Medicine Agency has granted the company's CPX-351 orphan drug designation for the treatment of acute myeloid leukemia.

CPX-351 has also been given orphan drug status for the same indication in the US.


CPX-351 is a liposomal formulation of daunorubicin, a chemotherapy agent. The company is currently investigating the use of this compound in the phase 2 trial for the treatment of AML. The company has completed two randomized, phase 2 studies evaluating CPX-351 and is preparing to initiate the phase 3 trial. One of the phase 2 trial was supported by the Leukemia and Lymphoma Society.

Lpath suspended dosing trial evaluating iSONEP and announced conference call

Lpath Inc, located in San Diego, CA, announced that the company has temporarily suspending dosing patients in the company's PEDIgree and Nexus trials due to the manufacturing issues originated from the company's fill/finish contractor, Formatech. The company plans to hold a conference call on Friday, Jan 27, 2012 at 8:45 Eastern Time to discuss the news and its outlook for 2012.

Based on the report, Formatech has not been in compliance with the US FDA's current Good Manufacturing Practic requirements during the period of time in which iSONEP clinical vials were filled.

As of now, the company has not received any complaints about safety issues associated with the dispensed iSONEP.

The company has initiated the manufacturing of additional drug substances and

Amgen to Acquire Micromet

Amgen announced that the company has entered into an agreement with Micromet for $11 per share in cash. The transaction is estimated to be worth approximately $1.16B.

The proposal has been approved unanimously by both Boards of Directors.

The transaction will let Amgen obtaining blinatumomab, a Bispecific T cell Engager antibody, that is currently being studied in a phase 2 trial for the treatment of acute lymphoblastic leukemia. It is also being investigated for the treatment of non-Hodgkin's lymphoma

Roche plans to acquire all outstanding share of Illumina

Roche announced that it is going to propose to acquire all outstanding shares of Illumina, a diagnostic company, to further strengthen its role in diagnostics R $44.50 per share in cash. Once the acquisition is complete, the company plans to combine Illumina with its Applied Science business and will move the headquarter of this business to San Diego, CA. The company intends to continue its operation in Penzberg, Germany.

The acquisition is estimated to cost Roche approximately

Spectrum acquired worldwide rights to Zevalin

Spectrum Pharmaceuticals announced that it has entered into an agreement with Bayer to acquire licensing rights to market Zevalin (ibritumomab) outside of the US from Bayer Health Care.This allows the company to market Zevalin worldwide.

Zevalin has been approved in more than 40 countries

Watson acquired Ascent and became the fifth largest generic company in Australia

Australian Open is in progress and Watson wants a share of the Australian generic market.

Watson announced that the company has acquired Ascent Pharmaceutical, an Australian and Southeast Asian Generic Pharmaceutical business of Strides Arcolab Ltd with AU$375M. The acquisition will make Watson the fifth largest generic company in Australia and will have presence in Southeast Asia.
This will also position Watson as the largest generic company in Singapore and establish Watson's presence in Malaysia, Hong Kong, Vietnam and Thailand.

Ascent has approximately 300 employees in Australia and

Velcade can now be used subcutaneously

Takeda announced that the FDA has approved the company's supplemental new drug application submitted seeking approval for the use of Velcade given subcutaneously in all indications.

Velcade (bortezomib) has been approved for the treatment of multiple myeloma and mantle cell lymphoma after at least one prior therapy.

Takeda conducted a randomized, phase III, open-label, international, non-inferiority trial evaluating bortezomib given subcutaneously in 222 patients with relapsed multiple myeloma. The study primary objective was to demonstrate the non-inferiorty of subcutaneous Velcade to intravenous Velcade. The objective was to attain at least 60% of the overall response

Pfizer launched OXECTA

Acura Pharmaceuticals announced that Pfizer has launched OXECTA (oxycodone)  5 mg and 7.5 mg tablets.

OXECTA (oxycodone) utilizes Acura's AVERSION technology that has been developed to discourage common methods of products that can be misused or

Idera releases positive results of phase 1b trial evaluating IMO-2055

Idera Pharmaceuticals releases favorable results of the phase 1b study evaluating IMO-2055 in combination with Tarceva and Avastin in patients with advanced non-small cell lung cancer.

The phase 1b trial evaluating IMO-2055 given with Tarceva and Avastin in 36 patients diagnosed with advanced non-small cell lung cancer who have previously failed one or more prior therapies. The trial showed that the combinations provided a median progression-free survival of 5.6 months and a median overall survival of 16 months. In addition, a disease control rate was 79%.

IMO-2055 was evaluated at four dose levels

ARIKACE's clinical hold was lifted

Insmed announced that the US FDA has lifted the clinical hold that was previously placed on ARIKACE in patients with non-tuberculous mycobacteria lung disease.

Insmed said the company continues to discuss with the FDA in regards to the clinical hold place on ARIKACE in Cystic Fibrosis patients with Pseudomonas lung infections.

The clinical holds were place on both programs after

Happy Lunar New Year!

Happy Lunar New Year from us at PharmaPodia!


May the year of the Dragon bring you, our readers, wonderful opportunities and great fortunes!

Best,

Team @ PharmaPodia

La Jolla Pharmaceutical acquires GCS-100 from Solana Therapeutics

La Jolla Pharmaceutical announced that it has entered into an agreement with Solana Therapeutics to acquire global development and commercialization rights to GCS-100.

GCS-100 is a novel galectin-3 inhibitor that is being investigated for the treatment of cancer and chronic organ failure.

The agent has been studied in preclinical, phase 1