r&d and approvals in regulated markets

8/14/2019 R&d and Approvals in Regulated Markets

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Aurobindo Pharmawins the largest number of ANDAs during the last three yearsIndian pharmaceutical companies have claimed nearly one third of the generic drugs

approved by US FDA, in the year 2009, according to the data provided by the agency.Indian

firms won 138 approvals from the total 483 generics approved by the US FDA, claiming over

31% of the abbreviated new drug applications (ANDAs) approved by the regulator of theworlds largest pharma market US FDA. India has over 100 manufacturing facilities

approved by US FDA the largest outside US. Among the Indian firms, the Hyderabad,

southern India-based Aurobindo Pharma secured the maximum number 24 ANDA

approvals during the year 2009 which included 18 final and 6 tentative approvals from US

FDA. Indias number two drug maker Dr Reddys Laboratories of Hyderabad won 16 ANDA

approvals. So is Indias largest drug firm by market value Sun Pharmaceutical Industries of

Mumbai. While Zydus Pharma and Wockhardt received 14 final and one tentative approvals

each, Glenmark Pharmas won 10 final ANDA approvals and four tentative approvals.

Daiichi-Ranbaxy received seven final approvals during 2009. Similarly, MatrixLaboratories, a subsidiary of Mylan Inc, received four final approval for the period. Alembic

and Orchid Chemicals got six approvals each in 2009.

Indian generic firms, together with their subsidiaries in US, have been winning a

considerable proportion of ANDA approvals for generics for the last three years. Of the total

1394 approvals of ANDAs during last three years by the US FDA Indian companies bagged

408 approvals. Again, Aurobindo claimed the highest number of ANDAs for the last three

years cumulatively. Aurobindo secured a total of 68 ANDAs approvals or the last three years

i.e. 2009, 2008 and 2007.

While Sun Pharma and Caraco Pharma got 67 approvals, Zydus Pharma won 31 approvalsduring these three years.Dr Reddys grabbed 43 ANDA approvals.The US FDA approved

483 ANDAs and 492 ANDAs during 2008 and 2007 respectively.

Whats is an ANDA?

Abbreviated New Drug Application (ANDA) are the applications submitted to US

FDA for approval of generics.An Abbreviated New Drug Application (ANDA) contains data

which when submitted to US FDAs Center for Drug Evaluation and Research, Office of

Generic Drugs, provides for the review and ultimate approval of a generic drug product.

Generic drug applications are termed abbreviated because they are generally not required toinclude preclinical (animal) and clinical (human) data to establish safety and effectiveness.

Instead, generic applicants must scientifically demonstrate that their product is bioequivalent

(i.e., performs in the same manner as the innovator drug). One way scientists demonstrate

bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24

to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the

generic drug, which they can then compare to that of the innovator drug. The generic version

must deliver the same amount of active ingredients into a patients bloodstream in the same

amount of time as the innovator drug. Once approved, an applicant may manufacture and

market the generic drug product to supply in US market. A generic drug product is one that is

comparable to an innovator drug product in dosage form, strength, route of administration,quality, performance characteristics and intended use. All approved products, both innovator


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and generic, are listed in FDAs Approved Drug Products with Therapeutic Equivalence

Evaluations (Orange Book).

Using bioequivalence as the basis for approving generic copies of drug products was

established by the Drug Price Competition and Patent Term Restoration Act of 1984, also

known as the Waxman-Hatch Act. This Act expedites the availability of less costly genericdrugs by permitting FDA to approve applications to market generic versions of brand-name

drugs without conducting costly and duplicative clinical trials. At the same time, the brand-

name companies can apply for up to five additional years longer patent protection for the new

medicines they developed to make up for time lost while their products were going through

US FDAs approval process. Brand-name drugs are subject to the same bioequivalence tests

as generics upon reformulation. Generic drug application reviewers focus on bioequivalence

data, chemistry and microbiology data, requests for plant inspection, and drug labeling

information.

Regulations state that applicants shall retain reserve samples of the tested productsadministered to study subjects and release these samples to FDA upon request. US FDA may

then analyze these retention samples to ensure that the BA/BE results upon which FDA bases

approval of New Drug Applications (NDA) and Abbreviated New Drug Applications

(ANDAs) are reliable

AUROBINDO PHARMA REGISTERS RECORD TURNOVER OF RS.4169.7 MILLION.

ROBUST GROWTH IN PROFITS DRIVEN BY STRONG FORMULATION EXPORTS.

SALES UP BY 28% PAT UP BY 147% FORMULATIONS SALES UP BY 125%


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Aurobindo Pharma Limited has registered a total income of Rs.4169.7 million (Rs.3233.4million), EBITDA of Rs. 661.5 million (Rs.361.4 million) and PAT of Rs.261.9 million(Rs.105.9 million) for the quarter ended December 31, 2005

During the quarter the sales, EBITDA and PAT had shown a growth of 28%, 83% and 147%respectively as compared to the corresponding quarter of previous year. EBITDA stands at

(11%) of sales.

The company's investments in the regulated markets have begun to show results. Export salesduring the quarter stood at Rs. 2338 million (Rs.1523 million) registering a growth of 54%.Exports now constitute 57% ($*%) of total sales.

The formulations sales have grown by 125% to Rs.925 million (Rs.412 million) and nowconstitute 23% (13%) of total sales.

The increased number of the regulatory approvals is expected to keep up the buoyancy in theformulations exports.

Ramping up of filings in US

Particulars Q3 FY06Cumulative as on Dec 31,

2005

USA USA

13 54

ANDAs 10 45

During the quarter Aurobindo has filed 10 ANDAs and 13 DMFs for US and has filed 70formulations filings in other markets. The total number of formulations filings now stands at

Aurobindo has filed additional 11 patents during the quarter and the cumulative filings standat 163 as of December 31, 2005.

US Market

Aurobindo is gaining acceptance in the USD market and the business in contributing to theperformance of the company. Aurobindo has received final approval for Amoxicillin Tabletsand Capsules, Cephalexin Capsules and Mirtazapine Orally Disintegrating Tablets (ODT)during this quarter enabling Aurobindo expand the product portfolio for the US market.

PEPFAR Program

During the quarter, Aurobindo had received 3 approvals. US FDA tentatively approvedLamivudine Oral Solution, Stavudine Oral Solution and Nevirapine Oral Suspension furtherstrengthening the product portfolio. Aurobindo's portfolio of products for the PEPFAR

program now stands at10.

Europe MarketEuropean market is one of the Key markets and Aurobindo has established subsidiaries /

branch offices in Netherlands, Italy and UK. During the quarter Medicine and Health productsRegulatory Agency (UK MHRA) approved its first formulation product for SertralineHydrochloride Tablets. During the quarter Aurobindo has received the approval for APIFlucloxacillin Sodium By European Directorate for the Quality of Medicines (EDQM).

Facility approval by UK MHRA

UK MHRA has recommended Aurobindo's Unit XII as a site to manufacture formulations forthe UK market. Apart from this approval, the Unit XII facility is also approved by otheraccredited regulatory agencies.

Surge in WHO Pre-qualification listDuring the quarter 8 ARV products of Aurobindo have been included in the WHO pre-


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r&d and approvals in regulated markets

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