Company Update (NASDAQ:CELG): Celgene Corporation’s Celgene International Sàrl Gets Positive CHMP Opinion to Expand REVLIMID Indication as Monotherapy in Multiple Myeloma


Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID® as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT). Once approved by the European Commission, REVLIMID® will be the first and only licensed maintenance treatment available to these patients.

Multiple myeloma is an incurable and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system.1 It is a rare but deadly disease—around 39,000 people are diagnosed with MM in Europe, and around 24,000 people die from the disease each year.2 The median age at diagnosis in Europe is between 65 and 70 years.3 In Europe, patients who are under 65 years, fit and in good clinical condition are typically considered eligible for ASCT.4

For newly diagnosed, transplant-eligible MM patients, key treatment goals are to obtain and to maintain a deep response to therapy, with the ultimate objective of delaying disease progression.5,6 These patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. This treatment approach has been an established standard of care for over 20 years.7Considering that over half of patients relapse within 2 to 3 years after ASCT,8,9 trials have been conducted to assess whether maintenance therapy following ASCT could enable more durable remissions.

“Studies show that maintenance treatment after ASCT with REVLIMID® may help control residual malignant cells and delay tumour growth by enhancing immune function,” says Professor Michel Attal, Executive Director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France. “Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies, that REVLIMID® maintenance after ASCT can halve the risk of disease progression by sustaining the response.”

The CHMP recommendation was based on the results of two cooperative group-led studies, CALGB 10010410 and IFM 2005-0211:

  • CALGB 100104 was a phase III, controlled, double-blind, multi-centre study of 460 patients with newly diagnosed MM undergoing ASCT who received continuous daily treatment with REVLIMID® or placebo until relapse.
  • IFM 2005-02 was an international, phase III, controlled, double-blind, multi-centre study of 614 patients newly diagnosed with MM who were randomized to receive a 2-month consolidation regimen post-ASCT of REVLIMID® monotherapy, followed by continuous daily treatment with either REVLIMID® or placebo until relapse.

In the two phase III studies, REVLIMID® monotherapy as maintenance treatment post-ASCT significantly reduced the risk of disease progression or death in patients with MM, leading to the studies being unblinded based on passing their pre-specified boundary for superiority at interim analysis.

In these studies, the safety profile was in line with other clinical data in newly diagnosed non-stem cell transplant (NSCT) and post-approval safety study in relapsed/refractory MM (rrMM). Across both phase III clinical studies, the most commonly reported adverse events (AE) were haematological and included neutropenia and thrombocytopenia. The most commonly reported non-haematological AE were infections. In both trials, an increased incidence rate of haematologic second primary malignancies (SPMs) has been observed in the REVLIMID® group compared with the placebo group. However, the CHMP positive opinion confirms that the benefit-risk ratio for REVLIMID® is positive in this expanded indication.

Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “Despite substantial progress made so far in multiple myeloma treatment, it remains an incurable disease. We welcome this CHMP opinion as it confirms the important role that REVLIMID® plays in treating multiple myeloma, extending the use of REVLIMID® across the disease continuum. At Celgene, we aspire to turn some of the most challenging diseases, like multiple myeloma, into manageable conditions. Therefore, we will continue to invest more than one-third of our revenues back into research and development.”

The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

Shares of Celgene closed yesterday at $111.53, down $2.45 or -2.15%. CELG has a 1-year high of $127 and a 1-year low of $93.05. The stock’s 50-day moving average is $116.17 and its 200-day moving average is $110.81.

On the ratings front, Celgene has been the subject of a number of recent research reports. In a report released today, Barclays analyst Geoff Meacham maintained a Hold rating on CELG, with a price target of $120, which implies an upside of 8% from current levels. Yesterday, Cantor’s Mara Goldstein reiterated a Buy rating on the stock and has a price target of $159.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Geoff Meacham and Mara Goldstein have a yearly average return of 11.7% and a loss of -1.1% respectively. Meacham has a success rate of 55% and is ranked #474 out of 4378 analysts, while Goldstein has a success rate of 39% and is ranked #3564.

Overall, 3 research analysts have assigned a Hold rating and 14 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $140.60 which is 26.1% above where the stock closed yesterday.

Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax.

 

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