Strides Arcolab Ltd Bangalore gets USFDA approval for Methoxsalen

strides Arcolab, a successful pharmaceutical organization, has well established itself in India as a producer of specialty generic drugs and biopharmaceutical agents. Apart from these two major categories, Strides has carved a name for itself for being among the world’s biggest manufacturer of soft gelatin capsules. It has also acquired Stelis biopharmaceuticals, which focusses on the development of biosimilars and its supply to the regulated US and European markets.

Based in Bengaluru, this pharma organization boasts of a state of the art manufacturing and research facility in 5 sites across the country, a presence in 75 countries, and an outstanding sales and commercial group to establish business relationships with the world to sell their products.

Their KRS Gardens site is the lead area for the manufacture of oral dosage forms, including capsules and tablets. This site recently was cleared by the USFDA, which now makes it capable of supplying generics and capsule shells to North America.

The latest feather in their cap is the USFDA approval of their Methoxsalen capsules. This product would be made available in 10 mg capsules and produced in the Bengaluru facitlity, which has been cleared by the local and international regulatory bodies.

Methoxsalen is a drug used in the management of skin conditions such as psoriasis, eczema, contact dermatitis and vitiligo. The drug acts best when used along with a secondary means of treatment, such as exposing the affected part of the skin to UV-A light. Different forms of cutaneous lymphomas have also been effectively controlled using Methoxalen, where it functions by altering the biochemical pathways in these damaged cells. Currently, the US drug market for Methoxsalen crosses US $13 million, which thus makes this product very viable in International markets.

 
Needless to say, this is a big move for Strides with a good potential and opportunity to further expand its global presence.

Dr. Jay Shinde

West Pharma ventures into India

he US based West Pharma has been a major player in providing packaging expertise to major pharmaceutical organizations around the globe. Their forte lies in parenteral preparations, container seals and closures for parenteral formulations, and stability testing of the packaged materials. Since its inception in 1923, West has been actively developing premium, yet pharmaceutically acceptable products and packaging materials for medical devices.

West’s most recent foray has been establishing its presence in India, in the city of Chennai. In June 201, they commenced the set-up of their manufacturing plant in Sri City, which was designed to take care of the global packaging material supply. In order to bring this into effect, they signed a 99 year lease, which gave them access to almost 75000 square metres of land in the Special Economic Zone (SEZ) in Southern India. This came with a plethora of privileges in construction, utility management, labor availability, export and import tax reductions, just to name a few. After the completion of the first phase, which began in August 2012, the unit is now operational and capable of producing metallic and elastomeric seals for parenteral/ injectables. Further construction is currently underway, where a ready-to-sterilize range of components would be manufactured in the first quarter of 2016.

Due to a very central location in the Indian subcontinent, the exports of these pharmaceutical seals to various biopharmaceutical customers in India and globally, would be far easier and practical.

The first phase has a built up area of about 15000 square metres, which is steadily on the rise, and upon completion of the functional offices and manufacturing stations, will shoot up to above 37000 square meters. The estimated date for completion of this project is in 2023. In the near future, West will file DMFs for its newly constructed plant with the USFDA and Canadian Pharmaceutical Bureau.

Dr. Jay Shinde

Afrezza (insulin human) inhalation powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.

The FDA has approved Afrezza (insulin human) inhalation powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.

An estimated 25.8 million (18.8 million diagnosed and 7.0 million undiagnosed) people in the United States or approximately 8.3 percent of the population–have diabetes. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.

The drug’s safety and effectiveness were evaluated in a total of 3,017 participants, 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24 week study. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4 percent.

Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.

Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.

The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.

The FDA is requiring the following post-marketing studies for Afrezza:

- a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;

- a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);

- two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.

Afrezza is manufactured by MannKind Corporation.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online:www.fda.gov/MedWatch/report.htm

- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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